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Medicine

Nifedipine 30 mg extended-release tablet

Nifedipine · Oral
Available on requestPrescription onlyUS FDAGeneric name

Nifedipine 30 mg extended-release tablet is a generic prescription medicine for oral use, made by 25 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.

Availability

Available on request

Export supply from India to licensed buyers

Typical lead time

On request

Counted from payment and complete documents

Shipping

Ambient

Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59°…

Key facts

Active ingredient (INN)
Nifedipine
Brand
Sold under the generic name
Strength
30 mg
Dosage form
Extended-release tablet
Route
Oral
Packs
100 tablets, 1000 tablets, 300 tablets and 106 more
Manufacturers
Zydus LifesciencesIndiaAlembic PharmaceuticalsIndiaAscend LaboratoriesIndiaAurobindo PharmaIndiaIngenus PharmaceuticalsOceanside PharmaceuticalsUpsher-Smith LaboratoriesChartwell RX25 labelers on the register
Origin register
US FDA, United States
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from moisture and humidity.
Cold chain
Not required on record
Prescription status
Prescription only
Controlled substance
Not recorded as controlled
ATC code
C08CA05 Nifedipine
HS code (indicative)
3004.90Indicative only. Your customs broker confirms the final tariff code.
Marketing category
marketed
Marketed since
27 September 2000
Identifiers
RxCUI 1812011, 198034, 1812013 +3DailyMed set ID 325acf27-4b2e-40e8-8344-bb6cc9959910, 1b98b011-793c-ed92-e063-6294a90ac2bc, b885b6b5-71c6-4799-8b23-5ee8c17938a0 +37NDC 71335-1550, 71610-841, 0904-7208 +37Application ANDA210614, ANDA202987, ANDA203126 +8

Record updated 12 November 2026

Documents available

Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.

No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.

Packs

A sample of 40 packs from 25 labelers. The register lists 109 packs for this generic presentation, and we confirm the exact pack on the quote.

PackCodeLabelerMarketed since
100 tablet, extended release in 1 bottle68382-685-01Zydus LifesciencesIndia2 February 2018
1000 tablet, extended release in 1 bottle68382-685-10Zydus LifesciencesIndia2 February 2018
300 tablet, extended release in 1 bottle68382-685-95Zydus LifesciencesIndia2 February 2018
100 tablet, extended release in 1 bottle68382-688-01Zydus LifesciencesIndia18 August 2018
500 tablet, extended release in 1 bottle68382-688-05Zydus LifesciencesIndia18 August 2018
1000 tablet, extended release in 1 bottle68382-688-10Zydus LifesciencesIndia18 August 2018
90 tablet, extended release in 1 bottle68382-688-16Zydus LifesciencesIndia18 August 2018
10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack68382-688-77Zydus LifesciencesIndia18 August 2018
300 tablet, extended release in 1 bottle68382-688-95Zydus LifesciencesIndia18 August 2018
1000 tablet, extended release in 1 bottle70771-1190-0Zydus LifesciencesIndia2 February 2018
100 tablet, extended release in 1 bottle70771-1190-1Zydus LifesciencesIndia2 February 2018
300 tablet, extended release in 1 bottle70771-1190-3Zydus LifesciencesIndia2 February 2018
1000 tablet, extended release in 1 bottle70771-1365-0Zydus LifesciencesIndia18 August 2018
100 tablet, extended release in 1 bottle70771-1365-1Zydus LifesciencesIndia18 August 2018
10 blister pack in 1 carton / 10 tablet, extended release in 1 blister pack70771-1365-4Zydus LifesciencesIndia18 August 2018
500 tablet, extended release in 1 bottle70771-1365-5Zydus LifesciencesIndia18 August 2018
300 tablet, extended release in 1 bottle70771-1365-7Zydus LifesciencesIndia18 August 2018
90 tablet, extended release in 1 bottle70771-1365-9Zydus LifesciencesIndia18 August 2018
100 tablet, extended release in 1 bottle46708-732-31Alembic PharmaceuticalsIndia23 November 2022
300 tablet, extended release in 1 bottle46708-732-63Alembic PharmaceuticalsIndia23 November 2022
1000 tablet, extended release in 1 bottle46708-732-91Alembic PharmaceuticalsIndia23 November 2022
100 tablet, extended release in 1 bottle62332-732-31Alembic PharmaceuticalsIndia23 November 2022
300 tablet, extended release in 1 bottle62332-732-63Alembic PharmaceuticalsIndia23 November 2022
1000 tablet, extended release in 1 bottle62332-732-91Alembic PharmaceuticalsIndia23 November 2022
100 tablet, extended release in 1 bottle67877-757-01Ascend LaboratoriesIndia30 March 2022
500 tablet, extended release in 1 bottle67877-757-05Ascend LaboratoriesIndia30 March 2022
300 tablet, extended release in 1 bottle67877-757-58Ascend LaboratoriesIndia30 March 2022
90 tablet, extended release in 1 bottle67877-757-90Ascend LaboratoriesIndia30 March 2022
100 tablet, extended release in 1 bottle59651-295-01Aurobindo PharmaIndia19 July 2021
100 tablet, film coated, extended release in 1 bottle50742-260-01Ingenus Pharmaceuticals12 March 2019
300 tablet, film coated, extended release in 1 bottle50742-260-03Ingenus Pharmaceuticals12 March 2019
30 tablet, film coated, extended release in 1 bottle50742-260-30Ingenus Pharmaceuticals12 March 2019
100 tablet, extended release in 1 bottle50742-620-01Ingenus Pharmaceuticals15 February 2017
100 tablet, extended release in 1 bottle68682-105-10Oceanside Pharmaceuticals18 October 2012
300 tablet, extended release in 1 bottle68682-105-30Oceanside Pharmaceuticals18 October 2012
100 tablet, film coated, extended release in 1 bottle68682-108-10Oceanside Pharmaceuticals27 September 2000
300 tablet, film coated, extended release in 1 bottle68682-108-30Oceanside Pharmaceuticals27 September 2000
100 tablet, film coated, extended release in 1 bottle24979-011-01Upsher-Smith Laboratories1 November 2014
300 tablet, film coated, extended release in 1 bottle24979-011-12Upsher-Smith Laboratories15 May 2015
90 tablet, film coated, extended release in 1 bottle62135-521-90Chartwell RX11 April 2023

Status by register

Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.

RegisterStatusSource
US FDAListed, marketedSource record for this pageChecked 12 November 2026
US FDAFirst approved 31 December 1981Drugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Import route

Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.

Import guides are available for 25 countries. Pick one to see its route summary.

BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides

Alternatives

Other makers and brands of Nifedipine 30 mg extended-release tablet.

Compare 1

Other strengths and forms of Nifedipine

Clinical summary

Nifedipine is a dihydropyridine calcium channel blocker indicated for the management of vasospastic angina confirmed by any of criteria, among other approved uses. It is available as extended-release tablets and capsules for oral use. MedsAcross supplies Nifedipine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Read about Nifedipine

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

Data sources

Need Nifedipine 30 mg extended-release tablet for your hospital or patient?

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