nifedipine

Generic: nifedipine

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

nifedipine 90 mg/1

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-262
Product ID 50742-262_eea6dbcf-5574-4b70-989a-14855dc162e1
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 50742262
Hyphenated Format 50742-262

Supplemental Identifiers

RxCUI
1812011 1812013 1812015
UPC
0350742260010 0350742261017 0350742262014
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 ANDA210614 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 90 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-262-01)
  • 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-262-03)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-262-30)
source: ndc

Packages (3)

50742-262-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-262-01) 50742-262-03 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-262-03) 50742-262-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-262-30)

Ingredients (1)

nifedipine (90 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": "eea6dbcf-5574-4b70-989a-14855dc162e1", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0350742260010", "0350742261017", "0350742262014"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812011", "1812013", "1812015"], "spl_set_id": ["4d3e11d2-d320-45d3-96c8-48322202b504"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-262-01)", "package_ndc": "50742-262-01", "marketing_start_date": "20190312"}, {"sample": false, "description": "300 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-262-03)", "package_ndc": "50742-262-03", "marketing_start_date": "20190312"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-262-30)", "package_ndc": "50742-262-30", "marketing_start_date": "20190312"}], "brand_name": "Nifedipine", "product_id": "50742-262_eea6dbcf-5574-4b70-989a-14855dc162e1", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "50742-262", "generic_name": "nifedipine", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "90 mg/1"}], "application_number": "ANDA210614", "marketing_category": "ANDA", "marketing_start_date": "20190312", "listing_expiration_date": "20261231"}