nifedipine

Generic: nifedipine

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler proficient rx lp
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 60 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-964
Product ID 71205-964_ba67d6b0-f638-4264-9bd4-1557223abe83
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203126
Listing Expiration 2026-12-31
Marketing Start 2014-11-01

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 71205964
Hyphenated Format 71205-964

Supplemental Identifiers

RxCUI
1812011 1812013 1812015
UPC
0371205963644 0371205964009 0371205965648
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 ANDA203126 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-00)
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-30)
  • 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-60)
  • 240 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-64)
  • 270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-67)
  • 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-72)
  • 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-78)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-90)
  • 300 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-96)
source: ndc

Packages (9)

Ingredients (1)

nifedipine (60 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "ba67d6b0-f638-4264-9bd4-1557223abe83", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0371205963644", "0371205964009", "0371205965648"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812011", "1812013", "1812015"], "spl_set_id": ["d428aa4d-4cc0-4b1e-b9f6-40ae65a735d6"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-00)", "package_ndc": "71205-964-00", "marketing_start_date": "20200609"}, {"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-30)", "package_ndc": "71205-964-30", "marketing_start_date": "20201006"}, {"sample": false, "description": "60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-60)", "package_ndc": "71205-964-60", "marketing_start_date": "20201006"}, {"sample": false, "description": "240 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-64)", "package_ndc": "71205-964-64", "marketing_start_date": "20201006"}, {"sample": false, "description": "270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-67)", "package_ndc": "71205-964-67", "marketing_start_date": "20201006"}, {"sample": false, "description": "120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-72)", "package_ndc": "71205-964-72", "marketing_start_date": "20201006"}, {"sample": false, "description": "180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-78)", "package_ndc": "71205-964-78", "marketing_start_date": "20201006"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-90)", "package_ndc": "71205-964-90", "marketing_start_date": "20201006"}, {"sample": false, "description": "300 TABLET, EXTENDED RELEASE in 1 BOTTLE (71205-964-96)", "package_ndc": "71205-964-96", "marketing_start_date": "20200609"}], "brand_name": "Nifedipine", "product_id": "71205-964_ba67d6b0-f638-4264-9bd4-1557223abe83", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "71205-964", "generic_name": "Nifedipine", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "60 mg/1"}], "application_number": "ANDA203126", "marketing_category": "ANDA", "marketing_start_date": "20141101", "listing_expiration_date": "20261231"}