nifedipine

Generic: nifedipine

Labeler: elite pharmaceutical solution, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nifedipine
Generic Name nifedipine
Labeler elite pharmaceutical solution, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

nifedipine 90 mg/1

Manufacturer
Elite Pharmaceutical Solution, Inc.

Identifiers & Regulatory

Product NDC 70807-503
Product ID 70807-503_3816123b-e06c-4abf-aead-2bed62b89c15
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212016
Listing Expiration 2027-12-31
Marketing Start 2021-10-15

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 70807503
Hyphenated Format 70807-503

Supplemental Identifiers

RxCUI
1812015
UPC
0370807503135
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 ANDA212016 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 90 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70807-503-12)
  • 300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70807-503-13)
source: ndc

Packages (2)

70807-503-12 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70807-503-12) 70807-503-13 300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70807-503-13)

Ingredients (1)

nifedipine (90 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": "3816123b-e06c-4abf-aead-2bed62b89c15", "openfda": {"nui": ["N0000000069", "N0000175421", "M0006414"], "upc": ["0370807503135"], "unii": ["I9ZF7L6G2L"], "rxcui": ["1812015"], "spl_set_id": ["1df07edb-630d-4c70-a68c-bdbc607ce850"], "pharm_class_cs": ["Dihydropyridines [CS]"], "pharm_class_epc": ["Dihydropyridine Calcium Channel Blocker [EPC]"], "pharm_class_moa": ["Calcium Channel Antagonists [MoA]"], "manufacturer_name": ["Elite Pharmaceutical Solution, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70807-503-12)", "package_ndc": "70807-503-12", "marketing_start_date": "20211015"}, {"sample": false, "description": "300 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70807-503-13)", "package_ndc": "70807-503-13", "marketing_start_date": "20211015"}], "brand_name": "nifedipine", "product_id": "70807-503_3816123b-e06c-4abf-aead-2bed62b89c15", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Calcium Channel Antagonists [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]"], "product_ndc": "70807-503", "generic_name": "nifedipine", "labeler_name": "Elite Pharmaceutical Solution, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nifedipine", "active_ingredients": [{"name": "NIFEDIPINE", "strength": "90 mg/1"}], "application_number": "ANDA212016", "marketing_category": "ANDA", "marketing_start_date": "20211015", "listing_expiration_date": "20271231"}