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 CAPSULE
Routes
ORAL
Active Ingredients

nifedipine 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7229
Product ID 0904-7229_4f81130b-db75-4292-9229-338914ccd6f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202644
Listing Expiration 2026-12-31
Marketing Start 2022-08-23

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 09047229
Hyphenated Format 0904-7229

Supplemental Identifiers

RxCUI
198032
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 ANDA202644 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7229-61) / 1 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

nifedipine (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4f81130b-db75-4292-9229-338914ccd6f3", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["I9ZF7L6G2L"], "rxcui": ["198032"], "spl_set_id": ["acb493a3-b8f2-41a9-8ab2-550d97c4592a"], "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": "100 BLISTER PACK in 1 CARTON (0904-7229-61)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "0904-7229-61", "marketing_start_date": "20220823"}], "brand_name": "Nifedipine", "product_id": "0904-7229_4f81130b-db75-4292-9229-338914ccd6f3", "dosage_form": "CAPSULE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "0904-7229", "generic_name": "Nifedipine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "10 mg/1"}], "application_number": "ANDA202644", "marketing_category": "ANDA", "marketing_start_date": "20220823", "listing_expiration_date": "20261231"}