nifedipine

Generic: nifedipine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler major pharmaceuticals
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 60 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7081
Product ID 0904-7081_af49dd32-02ac-47ab-b513-ca480fe8dc36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210614
Listing Expiration 2026-12-31
Marketing Start 2019-03-12

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 09047081
Hyphenated Format 0904-7081

Supplemental Identifiers

RxCUI
1812011 1812013 1812015
UPC
0309047080618
UNII
I9ZF7L6G2L
NUI
N0000000069 N0000175421 M0006414

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 ANDA210614 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (0904-7081-06) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (0904-7081-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

0904-7081-06 50 BLISTER PACK in 1 CARTON (0904-7081-06) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 0904-7081-61 100 BLISTER PACK in 1 CARTON (0904-7081-61) / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

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": "af49dd32-02ac-47ab-b513-ca480fe8dc36", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0309047080618"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812011", "1812013", "1812015"], "spl_set_id": ["41aa6fbd-96c1-40f7-92d4-cfdd2d5325e9"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-7081-06)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-7081-06", "marketing_start_date": "20190312"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7081-61)  / 1 TABLET, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-7081-61", "marketing_start_date": "20190312"}], "brand_name": "Nifedipine", "product_id": "0904-7081_af49dd32-02ac-47ab-b513-ca480fe8dc36", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "0904-7081", "generic_name": "nifedipine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "60 mg/1"}], "application_number": "ANDA210614", "marketing_category": "ANDA", "marketing_start_date": "20190312", "listing_expiration_date": "20261231"}