nifedipine

Generic: nifedipine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 30 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-689
Product ID 71610-689_57e2138d-9144-44c7-926e-73810d632cec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202987
Listing Expiration 2026-12-31
Marketing Start 2016-08-25

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 71610689
Hyphenated Format 71610-689

Supplemental Identifiers

RxCUI
198034
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 ANDA202987 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-53)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-60)
source: ndc

Packages (3)

71610-689-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-30) 71610-689-53 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-53) 71610-689-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-60)

Ingredients (1)

nifedipine (30 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": "57e2138d-9144-44c7-926e-73810d632cec", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["I9ZF7L6G2L"], "rxcui": ["198034"], "spl_set_id": ["75bb3a1f-3cb7-4450-8e59-27521a1ebc25"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-30)", "package_ndc": "71610-689-30", "marketing_start_date": "20230201"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-53)", "package_ndc": "71610-689-53", "marketing_start_date": "20230201"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-689-60)", "package_ndc": "71610-689-60", "marketing_start_date": "20230201"}], "brand_name": "Nifedipine", "product_id": "71610-689_57e2138d-9144-44c7-926e-73810d632cec", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "71610-689", "generic_name": "nifedipine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "30 mg/1"}], "application_number": "ANDA202987", "marketing_category": "ANDA", "marketing_start_date": "20160825", "listing_expiration_date": "20261231"}