nifedipine

Generic: nifedipine

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler oceanside pharmaceuticals
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 60 mg/1

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-109
Product ID 68682-109_68cca98c-658a-48b4-9630-478b62b1471e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075289
Listing Expiration 2027-12-31
Marketing Start 2000-09-27

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 68682109
Hyphenated Format 68682-109

Supplemental Identifiers

RxCUI
1812011 1812013
UPC
0368682108101
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 ANDA075289 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-10)
  • 300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-30)
source: ndc

Packages (2)

68682-109-10 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-10) 68682-109-30 300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-30)

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": "68cca98c-658a-48b4-9630-478b62b1471e", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0368682108101"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812011", "1812013"], "spl_set_id": ["c7874606-c71e-424c-b881-38697988e0d0"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-10)", "package_ndc": "68682-109-10", "marketing_start_date": "20000927"}, {"sample": false, "description": "300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-109-30)", "package_ndc": "68682-109-30", "marketing_start_date": "20000927"}], "brand_name": "nifedipine", "product_id": "68682-109_68cca98c-658a-48b4-9630-478b62b1471e", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "68682-109", "generic_name": "nifedipine", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "60 mg/1"}], "application_number": "ANDA075289", "marketing_category": "ANDA", "marketing_start_date": "20000927", "listing_expiration_date": "20271231"}