nifedipine

Generic: nifedipine

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 60 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8549
Product ID 0615-8549_6c94fb65-af22-4bfd-a639-2c9545775c54
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 06158549
Hyphenated Format 0615-8549

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 ANDA210614 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8549-39)
source: ndc

Packages (1)

0615-8549-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8549-39)

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": "6c94fb65-af22-4bfd-a639-2c9545775c54", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812013"], "spl_set_id": ["0cabe053-3b7e-4dcb-8441-ef7821bb6f68"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8549-39)", "package_ndc": "0615-8549-39", "marketing_start_date": "20241010"}], "brand_name": "Nifedipine", "product_id": "0615-8549_6c94fb65-af22-4bfd-a639-2c9545775c54", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "0615-8549", "generic_name": "nifedipine", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "60 mg/1"}], "application_number": "ANDA210614", "marketing_category": "ANDA", "marketing_start_date": "20190312", "listing_expiration_date": "20261231"}