Neocepri Endocyte Europe, B.V. · Application withdrawn · ATC V04
Therapeutic indication (EMA)
Indicated for the enhancement of 99mTc-etarfolatide single photon emission computed tomography (SPECT) image quality
Active substance
Folic acid
- SFDA 16
- US FDA 42
- EMA 1
- Health Canada 3
- US price lines 1
- NHS prices 4
- WHO EML 1
- Safety 6
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| BEFOLVIT 1MG TAB | 1 mg | Tablet · Oral use | 30 Blister | SAR 9.20 | Generic · OTC | KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES | Valid |
| BEFOLVIT 5 MG TAB | 5 mg | Tablet · Oral use | 30 Blister | SAR 9.20 | Generic · OTC | KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES | Valid |
| FOLIC ACID | 5 mg | Tablet · Oral use | 20 Blister | SAR 6.90 | Generic · OTC | RIYADH PHARMA | Valid |
| FOLIC ACID | 1 mg | Tablet · Oral use | 20 Blister | SAR 6.90 | Generic · OTC | RIYADH PHARMA | Valid |
| FOLICUM | 5 mg | Tablet · Oral use | 200 Blister | SAR 27.60 | Generic · OTC | Gulf Pharmaceutical Industries (Julphar) | Valid |
| FOLICUM | 1 mg | Tablet · Oral use | 200 Blister | SAR 24.85 | Generic · OTC | Gulf Pharmaceutical Industries (Julphar) | Valid |
| FOLICUM 1 MG TABLET | 1 mg | Tablet · Oral use | 20 Blister | SAR 6.15 | Generic · OTC | Gulf Pharmaceutical Industries (Julphar) | Valid |
| FOLICUM 5MG TAB | 5 mg | Tablet · Oral use | 20 Blister | SAR 6.15 | Generic · OTC | Gulf Pharmaceutical Industries (Julphar) | Valid |
| RAFOL 1 mg Tablet | 1 mg | Tablet · Oral use | 50 Blister | SAR 15.30 | Generic · OTC | Alrai Pharmaceutical industry Co. (L.L.C) | Valid |
| RAFOL 5 mg Tablet | 5 mg | Tablet · Oral use | 50 Blister | SAR 15.30 | Generic · OTC | Alrai Pharmaceutical industry Co. (L.L.C) | Valid |
| FOLIC ACID | 5 mg | Tablet · Oral use | 40 Blister | SAR 8.60 | Generic · OTC | RIYADH PHARMA | Withdrawn by MAH · Not Marketed |
| FOLIC ACID | 5 mg | Tablet · Oral use | 40 Blister | SAR 8.60 | Generic · OTC | RIYADH PHARMA | Withdrawn by MAH · Not Marketed |
| FOLIC ACID | 1 mg | Tablet · Oral use | 100 Blister | SAR 4.90 | Generic · OTC | RIYADH PHARMA | Withdrawn by MAH · Not Marketed |
| FOLINIL 5MG TABLET | 5 mg | Tablet · Oral use | 50 Blister | SAR 5.00 | Generic · OTC | THE NILE COMPANY FOR PHARMACEUTICALS AND CHEMICAL IND. | Suspended · Not Marketed |
| FOLIVITA TAB | 1 mg | Tablet · Oral use | 20 Blister | SAR 4.40 | Generic · OTC | Tabuk Pharmaceutical Manufacturing Company | Withdrawn by MAH · Not Marketed |
| VIFOLIN TAB 5 MG | 5 mg | Tablet · Oral use | 100 Blister | SAR 5.10 | Generic · OTC | APM | Invalid · Not Marketed |
Indications — CHI Daman Drug Formulary
CHRONIC MYELOID LEUKAEMIA (CML); ENTEROPATHIC ARTHROPATHIES, UNSPECIFIED SITE REACTIVE ARTHROPATHY, UNSPECIFIED; FOLATE DEFICIENCY ANEMIA; GRANULOMATOSIS WITH POLYANGIITIS AND MICROSCOPIC POLYANGIITIS; Non INFECTIOUS UVEITIS; JUVENILE IDIOPATHIC ARTHRITIS (JIA); LICHEN PLANUS; MATERNAL AND CHILD HEALTHCARE- SUPPLEMENTATION FOR MOTHER AND CHILD; MYASTHENIA GRAVIS; MYELOFIBROSIS-ADVERSE REACTION MANAGEMENT; NON-SMALL-CELL LUNG CARCINOMA (NSCLC); PSORIATIC ARTHRITIS; RHEUMATOID ARITHRITIS-SUPPORTIVE CARE AND ADRS MANAGEMENT; SYSTEMIC LUPUS ERYTHEMATOSUS; T-CELL LYMPHOMA; THROMBOTIC THROMBOCYTOPENIC PURPURA
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FOLIC ACID | 1MG | tablet · oral | WATSON LABS | Prescription | 23 Dec 1971 |
| FOLIC ACID | 5MG/ML | injectable · injection | FRESENIUS KABI USA | Prescription | 18 Feb 1986 |
| FOLIC ACID | 1MG | tablet · oral | AMNEAL PHARM | Prescription | 21 Jul 2005 |
| FOLIC ACID | 1MG | tablet · oral | LEADING | Prescription | 12 Jan 2009 |
| FOLIC ACID | 1MG | tablet · oral | CHARTWELL MOLECULAR | Prescription | 9 Jun 2009 |
| FOLIC ACID | 1MG | tablet · oral | AIPING PHARM INC | Prescription | 12 Jul 2013 |
| FOLIC ACID | 1MG | tablet · oral | CADILA PHARMS LTD | Prescription | 27 Jan 2014 |
| FOLIC ACID | 1MG | tablet · oral | NUVO PHARMS INC | Prescription | 28 Jul 2015 |
| FOLIC ACID | 1MG | tablet · oral | RISING | Prescription | 8 Mar 2019 |
| FOLIC ACID | 5MG/ML | injectable · injection | XGEN PHARMS | Prescription | 6 Nov 2019 |
| QUIOFIC | 0.2MG/ML | solution · oral | SOLUBIOMIX | Prescription | 26 Jan 2026 |
| FOLIC ACID | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | LILLY | Discontinued | 2 Jun 1947 |
| FOLVITE | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | WYETH PHARMS INC | Discontinued | 5 Jun 1947 |
| FOLVITE | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | WYETH PHARMS INC | Discontinued | 5 Jun 1947 |
| FOLIC ACID | 1MG | tablet · oral | HIKMA PHARMS | Discontinued | 31 Mar 1972 |
| FOLIC ACID | 1MG | tablet · oral | IVAX SUB TEVA PHARMS | Discontinued | 2 Oct 1972 |
| FOLIC ACID | 1MG | tablet · oral | PUREPAC PHARM | Discontinued | 2 Nov 1972 |
| FOLIC ACID | 1MG | tablet · oral | WATSON LABS | Discontinued | 15 Feb 1973 |
| FOLIC ACID | 1MG | tablet · oral | EVERYLIFE | Discontinued | 20 Mar 1973 |
| FOLIC ACID | 1MG | tablet · oral | TABLICAPS | Discontinued | 24 Apr 1973 |
| FOLIC ACID | 1MG | tablet · oral | IMPAX LABS | Discontinued | 20 Jul 1973 |
| FOLIC ACID | 1MG | tablet · oral | WHITEWORTH TOWN PLSN | Discontinued | 31 Jul 1973 |
| FOLIC ACID | 1MG | tablet · oral | MK LABS | Discontinued | 13 Nov 1973 |
| FOLIC ACID | 1MG | tablet · oral | LANNETT | Discontinued | 6 May 1974 |
| FOLIC ACID | 1MG | tablet · oral | PHARMERAL | Discontinued | 8 May 1974 |
17 more — full table
EMA European Union — centrally authorised medicines
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| FOLIC ACID | 00426849 | 5 MG | TABLET · ORAL | AA PHARMA INC |
| FOLIC ACID INJECTION, USP | 02139480 | 5 MG / ML | SOLUTION · SUBCUTANEOUS; INTRAMUSCULAR; INTRAVENOUS | FRESENIUS KABI CANADA LTD |
| JAMP-FOLIC ACID | 02366061 | 5 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | FOLIC ACID 1 MG TABLET | $0.02013 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Folic acid 2.5mg/5ml oral solution sugar free | £9.16 | 150 ml | 1 Oct 2026 |
| NHS Drug Tariff | Folic acid 400microgram tablets | £8.94 | 90 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Folic acid 5mg tablets | £0.74 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Folic acid 5mg/5ml oral solution sugar free | £87.96 | 150 ml | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 10.1. Antianaemia medicines · core
Cephalocele; Anencephaly or similar anomalies; Spina bifida; Folate deficiency anaemia
Oral > Solid: 400 µg | Oral > Liquid: 1 mg per mL (EMLc) | Oral > Solid: 1 mg tablet; 5 mg tablet
Safety signals and safety-related labeling changes
- EMA PRAC 4 Sep 2025 PRAC signal: Increased risk of cancer with high-dose folic acid (≥1mg)
Action for MAH: update of the product information: No - US FDA 6 Nov 2024 INFUVITE ADULT — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 6 Nov 2024 INFUVITE PEDIATRIC — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 16 Dec 2020 M.V.I. ADULT — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 Nov 2017 M.V.I. ADULT (PHARMACY BULK PACKAGE) — safety-related labeling change
Labeling sections changed: Contraindications; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 Nov 2017 M.V.I.-12 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Combinations containing Folic acid
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.