nifedipine

Generic: nifedipine

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler a-s medication solutions
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 60 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6767
Product ID 50090-6767_db03e3bc-412a-4336-a97c-dbcdb4bbc1bc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216067
Listing Expiration 2026-12-31
Marketing Start 2022-03-30

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 500906767
Hyphenated Format 50090-6767

Supplemental Identifiers

RxCUI
1812013
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 ANDA216067 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-0)
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-1)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-2)
source: ndc

Packages (3)

50090-6767-0 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-0) 50090-6767-1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-1) 50090-6767-2 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-2)

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": "db03e3bc-412a-4336-a97c-dbcdb4bbc1bc", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812013"], "spl_set_id": ["4a4d5b67-6ce7-4098-9324-f68084e800e4"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-0)", "package_ndc": "50090-6767-0", "marketing_start_date": "20231020"}, {"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-1)", "package_ndc": "50090-6767-1", "marketing_start_date": "20231020"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-6767-2)", "package_ndc": "50090-6767-2", "marketing_start_date": "20231020"}], "brand_name": "Nifedipine", "product_id": "50090-6767_db03e3bc-412a-4336-a97c-dbcdb4bbc1bc", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "50090-6767", "generic_name": "Nifedipine", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "60 mg/1"}], "application_number": "ANDA216067", "marketing_category": "ANDA", "marketing_start_date": "20220330", "listing_expiration_date": "20261231"}