nifedipine

Generic: nifedipine

Labeler: legacy pharmaceutical packaging, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler legacy pharmaceutical packaging, llc
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 60 mg/1

Manufacturer
Legacy Pharmaceutical Packaging, LLC

Identifiers & Regulatory

Product NDC 68645-604
Product ID 68645-604_4743ad3c-0518-566c-e063-6294a90aa06f
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 68645604
Hyphenated Format 68645-604

Supplemental Identifiers

RxCUI
1812011 1812013
UPC
0368645604541 0368645603544
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
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68645-604-54)
source: ndc

Packages (1)

68645-604-54 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68645-604-54)

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": "4743ad3c-0518-566c-e063-6294a90aa06f", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0368645604541", "0368645603544"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812011", "1812013"], "spl_set_id": ["e65e1547-08ef-6682-e053-2a95a90a51b7"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Legacy Pharmaceutical Packaging, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68645-604-54)", "package_ndc": "68645-604-54", "marketing_start_date": "20220816"}], "brand_name": "Nifedipine", "product_id": "68645-604_4743ad3c-0518-566c-e063-6294a90aa06f", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "68645-604", "generic_name": "Nifedipine", "labeler_name": "Legacy Pharmaceutical Packaging, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "60 mg/1"}], "application_number": "ANDA077127", "marketing_category": "ANDA", "marketing_start_date": "20051121", "listing_expiration_date": "20261231"}