nifedipine

Generic: nifedipine

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 60 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-485
Product ID 72789-485_48387f23-9c80-d037-e063-6294a90a1ae3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216067
Listing Expiration 2027-12-31
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 72789485
Hyphenated Format 72789-485

Supplemental Identifiers

RxCUI
1812013
UPC
0372789485010
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
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-485-01)
  • 300 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-485-87)
source: ndc

Packages (2)

72789-485-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-485-01) 72789-485-87 300 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-485-87)

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": "48387f23-9c80-d037-e063-6294a90a1ae3", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0372789485010"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812013"], "spl_set_id": ["7160331a-8735-4bc0-8cb9-a8014512a669"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-485-01)", "package_ndc": "72789-485-01", "marketing_start_date": "20250212"}, {"sample": false, "description": "300 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-485-87)", "package_ndc": "72789-485-87", "marketing_start_date": "20250210"}], "brand_name": "Nifedipine", "product_id": "72789-485_48387f23-9c80-d037-e063-6294a90a1ae3", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "72789-485", "generic_name": "Nifedipine", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "20271231"}