nifedipine

Generic: nifedipine

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 90 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-687
Product ID 68382-687_c0025ef1-99d7-4b31-9d99-4be010b2b9fb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210012
Listing Expiration 2026-12-31
Marketing Start 2018-02-02

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 68382687
Hyphenated Format 68382-687

Supplemental Identifiers

RxCUI
1812011 1812013 1812015
UPC
0368382687012 0368382686015 0368382685018
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 ANDA210012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 90 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-01)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-10)
  • 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-95)
source: ndc

Packages (3)

68382-687-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-01) 68382-687-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-10) 68382-687-95 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-95)

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": "c0025ef1-99d7-4b31-9d99-4be010b2b9fb", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0368382687012", "0368382686015", "0368382685018"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812011", "1812013", "1812015"], "spl_set_id": ["657221d5-9eb8-42f9-8cdc-39cefc386f51"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-01)", "package_ndc": "68382-687-01", "marketing_start_date": "20180202"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-10)", "package_ndc": "68382-687-10", "marketing_start_date": "20180202"}, {"sample": false, "description": "300 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-687-95)", "package_ndc": "68382-687-95", "marketing_start_date": "20180202"}], "brand_name": "Nifedipine", "product_id": "68382-687_c0025ef1-99d7-4b31-9d99-4be010b2b9fb", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "68382-687", "generic_name": "Nifedipine", "labeler_name": "Zydus Pharmaceuticals (USA) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "90 mg/1"}], "application_number": "ANDA210012", "marketing_category": "ANDA", "marketing_start_date": "20180202", "listing_expiration_date": "20261231"}