Regulatory PathRegulatory requirements compared

Active substance

Nifedipine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ADALAT 30MG LA TAB30 mgmodified-release tablet · Oral use30 BlisterSAR 46.40NCE · PrescriptionBAYER PHARMA AGValid
EPILAT 10MG CAPS10 mgCapsule, soft · Oral use30 BlisterSAR 6.45Generic · PrescriptionEIPICOValid
ADALAT 60MG LA TAB60 mgmodified-release tablet · Oral use30 BlisterSAR 58.50NCE · PrescriptionBAYER PHARMA AGWithdrawn by MAH · Not Marketed
ADALAT CAP 10MG10 mgCapsule · Oral use30 BlisterSAR 28.70NCE · PrescriptionBAYER PHARMA AGWithdrawn by MAH · Not Marketed
ADALAT RETARD 20MG TABS20 mgmodified-release tablet · Oral use30 BlisterSAR 37.65NCE · PrescriptionBAYER PHARMA AGWithdrawn by MAH · Not Marketed
NIFECARD 10 CAPS10 mgCapsule · Oral use30 BlisterSAR 16.30Generic · PrescriptionDAR ALDAWAWithdrawn by MAH · Not Marketed
NOVO-NIFEDIN 10MG CAPS.10 mgCapsule, soft · Oral use30 BlisterSAR 24.65Generic · PrescriptionNOVOPHARMWithdrawn by MAH · Not Marketed
NOVO-NIFEDIN 10MG CAPS.10 mgCapsule, soft · Oral use100 BlisterSAR 78.35Generic · PrescriptionNOVOPHARMWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ANAL FISSURE; CHRONIC KIDNEY DISEASE; CORONARY ARTERY DISEASE; HYPERTENSION; MATERNAL AND CHILD HEALTHCARE- PREVENTION OF PRETERM LABOR AND BIRTH; NEONATAL RESPIRATORY DISTRESS SYNDROME (NRDS); PRE-ECLAMPSIA; PULMONARY ARTERIAL HYPERTENSION; RAYNAUD'S PHENOMENON; RENAL AND URETERIC STONES; SYSTEMIC LUPUS ERYTHEMATOSUS; TREATMENT OF ALTITUDE SICKNESS

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
NIFEDIPINE10MGcapsule · oralACTAVIS ELIZABETHPrescription28 Apr 1989
PROCARDIA XL30MG; 60MGtablet, extended release · oralPFIZERPrescription6 Sep 1989
NIFEDIPINE10MGcapsule · oralVELZEN PHARMA PVTPrescription8 Oct 1991
NIFEDIPINE20MGcapsule · oralVELZEN PHARMA PVTPrescription30 Apr 1992
NIFEDIPINE10MGcapsule · oralACELLAPrescription30 Jul 1993
NIFEDIPINE60MG; 30MGtablet, extended release · oralVALEANT PHARMS NORTHPrescription27 Sep 2000
NIFEDIPINE30MG; 60MGtablet, extended release · oralVALEANT PHARMS NORTHPrescription4 Dec 2000
NIFEDIPINE90MGtablet, extended release · oralVALEANT PHARMS NORTHPrescription16 Aug 2002
NIFEDIPINE90MGtablet, extended release · oralMARTEC USA LLCPrescription23 Mar 2004
NIFEDIPINE30MG; 60MG; 90MGtablet, extended release · oralOSMOTICA PHARM USPrescription21 Nov 2005
NIFEDIPINE10MG; 20MGcapsule · oralHERITAGE PHARMAPrescription25 Apr 2013
NIFEDIPINE30MG; 60MG; 90MGtablet, extended release · oralTWI PHARMSPrescription3 Apr 2014
NIFEDIPINE30MG; 60MG; 90MGtablet, extended release · oralNOVAST LABSPrescription25 Aug 2016
NIFEDIPINE30MG; 60MG; 90MGtablet, extended release · oralZYDUS PHARMSPrescription19 Dec 2017
NIFEDIPINE30MG; 60MG; 90MGtablet, extended release · oralZYDUS PHARMSPrescription29 Jun 2018
NIFEDIPINE30MG; 60MG; 90MGtablet, extended release · oralNOVAST LABSPrescription12 Mar 2019
NIFEDIPINE90MGtablet, extended release · oralELITE PHARM SOLUTIONPrescription18 Nov 2020
NIFEDIPINE30MG; 60MG; 90MGtablet, extended release · oralAUROBINDO PHARMAPrescription19 Jul 2021
NIFEDIPINE30MG; 60MG; 90MGtablet, extended release · oralALKEM LABS LTDPrescription29 Mar 2022
NIFEDIPINE30MG; 60MG; 90MGtablet, extended release · oralALEMBICPrescription18 Nov 2022
PROCARDIA10MG; 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralPFIZERDiscontinued31 Dec 1981
ADALAT10MG; 20MGcapsule · oralBAYER PHARMSDiscontinued27 Nov 1985
NIFEDIPINE20MGcapsule · oralACTAVIS ELIZABETHDiscontinued28 Apr 1989
NIFEDIPINE10MGcapsule · oralCHASE LABS NJDiscontinued10 Jul 1989
PROCARDIA XL90MGtablet, extended release · oralPFIZERDiscontinued6 Sep 1989

13 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ADALAT XL0215590730 MGTABLET (EXTENDED-RELEASE) · ORALBAYER INC
AG-NIFEDIPINE ER0251146060 MGTABLET (EXTENDED-RELEASE) · ORALANGITA PHARMA INC.
JAMP NIFEDIPINE ER0251171160 MGTABLET (EXTENDED-RELEASE) · ORALJAMP PHARMA CORPORATION
M-NIFEDIPINE ER0251164960 MGTABLET (EXTENDED-RELEASE) · ORALMANTRA PHARMA INC
MYLAN-NIFEDIPINE EXTENDED RELEASE0232114960 MGTABLET (EXTENDED-RELEASE) · ORALMYLAN PHARMACEUTICALS ULC
MYLAN-NIFEDIPINE EXTENDED RELEASE0234916730 MGTABLET (EXTENDED-RELEASE) · ORALMYLAN PHARMACEUTICALS ULC
NIFEDIPINE007251105 MGCAPSULE · ORALAA PHARMA INC
NIFEDIPINE0075590710 MGCAPSULE · ORALAA PHARMA INC
NIFEDIPINE ER0242165860 MGTABLET (EXTENDED-RELEASE) · ORALPRO DOC LIMITEE
PMS-NIFEDIPINE ER0241630160 MGTABLET (EXTENDED-RELEASE) · ORALPHARMASCIENCE INC
PMSC-NIFEDIPINE ER0253333230 MGTABLET (EXTENDED-RELEASE) · ORALPHARMASCIENCE INC
PRO-NIFEDIPINE ER0253484330 MGTABLET (EXTENDED-RELEASE) · ORALPRO DOC LIMITEE

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACNIFEDIPINE 10 MG CAPSULE$0.25672per EA23 Sep 2026
US NADACNIFEDIPINE 20 MG CAPSULE$0.68559per EA23 Sep 2026
US NADACNIFEDIPINE ER 30 MG TABLET$0.13006per EA23 Sep 2026
US NADACNIFEDIPINE ER 30 MG TABLET$0.11663per EA23 Sep 2026
US NADACNIFEDIPINE ER 60 MG TABLET$0.16809per EA23 Sep 2026
US NADACNIFEDIPINE ER 60 MG TABLET$0.16266per EA23 Sep 2026
US NADACNIFEDIPINE ER 90 MG TABLET$0.26915per EA23 Sep 2026
US NADACNIFEDIPINE ER 90 MG TABLET$0.25884per EA23 Sep 2026
NHS Drug TariffNifedipine 10mg capsules£77.9490 capsule1 Oct 2026
NHS Drug TariffNifedipine 10mg modified-release capsules£3.9060 capsule1 Oct 2026
NHS Drug TariffNifedipine 10mg modified-release tablets£9.2356 tablet1 Oct 2026
NHS Drug TariffNifedipine 20mg modified-release capsules£5.4160 capsule1 Oct 2026
NHS Drug TariffNifedipine 20mg modified-release tablets£10.0656 tablet1 Oct 2026
NHS Drug TariffNifedipine 30mg modified-release capsules£4.8928 capsule1 Oct 2026
NHS Drug TariffNifedipine 30mg modified-release tablets£9.7028 tablet1 Oct 2026
NHS Drug TariffNifedipine 5mg capsules£63.6090 capsule1 Oct 2026
NHS Drug TariffNifedipine 60mg modified-release capsules£7.3428 capsule1 Oct 2026
NHS Drug TariffNifedipine 60mg modified-release tablets£11.2028 tablet1 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)

  • 22.5. Antioxytocics (tocolytics) · core
    Preterm labour without delivery
    Oral > Solid: 10 mg (immediate-release)

Combinations containing Nifedipine

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.