nifedipine er

Generic: nifedipine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

nifedipine 30 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-597
Product ID 50268-597_47e7d21f-e346-6413-e063-6294a90aa9be
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077127
Listing Expiration 2027-12-31
Marketing Start 2011-02-11

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 50268597
Hyphenated Format 50268-597

Supplemental Identifiers

RxCUI
1812011 1812013 1812015
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 er (source: ndc)
Generic Name nifedipine (source: ndc)
Application Number ANDA077127 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-597-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-597-11)
source: ndc

Packages (1)

50268-597-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-597-15) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-597-11)

Ingredients (1)

nifedipine (30 mg/1)

Linked Drug Pages (1)

Nifedipine ER ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47e7d21f-e346-6413-e063-6294a90aa9be", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812011", "1812013", "1812015"], "spl_set_id": ["d1a78ff2-7672-3e69-00ef-63d203c80484"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-597-15)  / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (50268-597-11)", "package_ndc": "50268-597-15", "marketing_start_date": "20110211"}], "brand_name": "Nifedipine ER", "product_id": "50268-597_47e7d21f-e346-6413-e063-6294a90aa9be", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "50268-597", "generic_name": "Nifedipine", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nifedipine", "brand_name_suffix": "ER", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "30 mg/1"}], "application_number": "ANDA077127", "marketing_category": "ANDA", "marketing_start_date": "20110211", "listing_expiration_date": "20271231"}