nifedipine

Generic: nifedipine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler aurobindo pharma limited
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 60 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-296
Product ID 59651-296_4d72a04e-43a6-4fa4-bd1c-1360c4539d71
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213361
Listing Expiration 2026-12-31
Marketing Start 2021-07-19

Pharmacologic Class

Established (EPC)
dihydropyridine calcium channel blocker [epc]
Mechanism of Action
calcium channel antagonists [moa]
Chemical Structure
dihydropyridines [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651296
Hyphenated Format 59651-296

Supplemental Identifiers

RxCUI
198034 198035 198036
UNII
I9ZF7L6G2L
NUI
N0000000069 N0000175421 M0006414

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name nifedipine (source: ndc)
Generic Name nifedipine (source: ndc)
Application Number ANDA213361 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-296-01)
source: ndc

Packages (1)

59651-296-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-296-01)

Ingredients (1)

nifedipine (60 mg/1)

Linked Drug Pages (1)

Nifedipine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4d72a04e-43a6-4fa4-bd1c-1360c4539d71", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["I9ZF7L6G2L"], "rxcui": ["198034", "198035", "198036"], "spl_set_id": ["eb70b7ff-f9f0-41d0-901a-f4c04ae9ed46"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (59651-296-01)", "package_ndc": "59651-296-01", "marketing_start_date": "20210719"}], "brand_name": "Nifedipine", "product_id": "59651-296_4d72a04e-43a6-4fa4-bd1c-1360c4539d71", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "59651-296", "generic_name": "Nifedipine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "60 mg/1"}], "application_number": "ANDA213361", "marketing_category": "ANDA", "marketing_start_date": "20210719", "listing_expiration_date": "20261231"}