nifedipine

Generic: nifedipine

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler leading pharma, llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nifedipine 10 mg/1

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-211
Product ID 69315-211_4f9b849c-719a-492b-9889-6766a4544c54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073250
Listing Expiration 2026-12-31
Marketing Start 2016-11-23

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 69315211
Hyphenated Format 69315-211

Supplemental Identifiers

RxCUI
198032
UPC
0369315211014
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 ANDA073250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE, PLASTIC (69315-211-01)
source: ndc

Packages (1)

69315-211-01 100 CAPSULE in 1 BOTTLE, PLASTIC (69315-211-01)

Ingredients (1)

nifedipine (10 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": "4f9b849c-719a-492b-9889-6766a4544c54", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0369315211014"], "unii": ["I9ZF7L6G2L"], "rxcui": ["198032"], "spl_set_id": ["10b854c5-e7b3-46bd-b4d6-788ba5d601e1"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE, PLASTIC (69315-211-01)", "package_ndc": "69315-211-01", "marketing_start_date": "20181002"}], "brand_name": "NIFEdipine", "product_id": "69315-211_4f9b849c-719a-492b-9889-6766a4544c54", "dosage_form": "CAPSULE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "69315-211", "generic_name": "NIFEdipine", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NIFEdipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "10 mg/1"}], "application_number": "ANDA073250", "marketing_category": "ANDA", "marketing_start_date": "20161123", "listing_expiration_date": "20261231"}