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 60 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-012
Product ID 71610-012_15325d8c-d716-9819-e063-6294a90a06d9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075269
Listing Expiration 2026-12-31
Marketing Start 2000-12-04

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 71610012
Hyphenated Format 71610-012

Supplemental Identifiers

RxCUI
198035
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 ANDA075269 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 4000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-04)
  • 6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-16)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-60)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-80)
source: ndc

Packages (4)

71610-012-04 4000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-04) 71610-012-16 6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-16) 71610-012-60 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-60) 71610-012-80 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-80)

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": "15325d8c-d716-9819-e063-6294a90a06d9", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["I9ZF7L6G2L"], "rxcui": ["198035"], "spl_set_id": ["81e6c8e7-e826-4abb-ad58-1dee62091a66"], "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": "4000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-04)", "package_ndc": "71610-012-04", "marketing_start_date": "20240402"}, {"sample": false, "description": "6000 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-16)", "package_ndc": "71610-012-16", "marketing_start_date": "20210920"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-60)", "package_ndc": "71610-012-60", "marketing_start_date": "20171115"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-012-80)", "package_ndc": "71610-012-80", "marketing_start_date": "20190501"}], "brand_name": "Nifedipine", "product_id": "71610-012_15325d8c-d716-9819-e063-6294a90a06d9", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "71610-012", "generic_name": "Nifedipine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "60 mg/1"}], "application_number": "ANDA075269", "marketing_category": "ANDA", "marketing_start_date": "20001204", "listing_expiration_date": "20261231"}