nifedipine

Generic: nifedipine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

nifedipine 60 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-758
Product ID 67877-758_2833cb85-4017-41e2-aa4a-c19371ba85e8
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 67877758
Hyphenated Format 67877-758

Supplemental Identifiers

RxCUI
1812011 1812013 1812015
UPC
0367877758589
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 ANDA216067 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-01)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-05)
  • 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-58)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-90)
source: ndc

Packages (4)

67877-758-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-01) 67877-758-05 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-05) 67877-758-58 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-58) 67877-758-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-90)

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": "2833cb85-4017-41e2-aa4a-c19371ba85e8", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0367877758589"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812011", "1812013", "1812015"], "spl_set_id": ["f661c1d9-f0f6-4595-82dd-f656bff974f1"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-01)", "package_ndc": "67877-758-01", "marketing_start_date": "20220330"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-05)", "package_ndc": "67877-758-05", "marketing_start_date": "20220330"}, {"sample": false, "description": "300 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-58)", "package_ndc": "67877-758-58", "marketing_start_date": "20220330"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (67877-758-90)", "package_ndc": "67877-758-90", "marketing_start_date": "20220330"}], "brand_name": "Nifedipine", "product_id": "67877-758_2833cb85-4017-41e2-aa4a-c19371ba85e8", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "67877-758", "generic_name": "Nifedipine", "labeler_name": "Ascend Laboratories, LLC", "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"}