nifedipine

Generic: nifedipine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 30 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-798
Product ID 55289-798_419b65f7-5d45-aff4-e063-6294a90a2a36
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077127
Listing Expiration 2026-12-31
Marketing Start 2005-11-21

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 55289798
Hyphenated Format 55289-798

Supplemental Identifiers

RxCUI
1812011
UPC
0355289798309
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 ANDA077127 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-798-07)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-798-30)
source: ndc

Packages (2)

55289-798-07 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-798-07) 55289-798-30 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-798-30)

Ingredients (1)

nifedipine (30 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": "419b65f7-5d45-aff4-e063-6294a90a2a36", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0355289798309"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812011"], "spl_set_id": ["86c1bdae-c749-4ec3-90f6-7ebe8e76c461"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-798-07)", "package_ndc": "55289-798-07", "marketing_start_date": "20111021"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55289-798-30)", "package_ndc": "55289-798-30", "marketing_start_date": "20111021"}], "brand_name": "Nifedipine", "product_id": "55289-798_419b65f7-5d45-aff4-e063-6294a90a2a36", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "55289-798", "generic_name": "Nifedipine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "30 mg/1"}], "application_number": "ANDA077127", "marketing_category": "ANDA", "marketing_start_date": "20051121", "listing_expiration_date": "20261231"}