metformin hcl

Generic: metformin hcl

Labeler: time cap laboratories, inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hcl
Generic Name metformin hcl
Labeler time cap laboratories, inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
TIME CAP LABORATORIES, INC

Identifiers & Regulatory

Product NDC 49483-620
Product ID 49483-620_2dc48b61-581f-fe5c-e063-6394a90aa557
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090888
Listing Expiration 2026-12-31
Marketing Start 2016-11-14

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49483620
Hyphenated Format 49483-620

Supplemental Identifiers

RxCUI
861004 861007 861010
UPC
0349483622102 0349483621013 0349483621105 0349483621815 0349483622812 0349483620818 0349483622010 0349483620016
UNII
786Z46389E

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 metformin hcl (source: ndc)
Generic Name metformin hcl (source: ndc)
Application Number ANDA090888 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-620-01)
  • 1000 TABLET, FILM COATED in 1 PACKAGE (49483-620-10)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-620-50)
  • 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-620-81)
source: ndc

Packages (4)

49483-620-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-620-01) 49483-620-10 1000 TABLET, FILM COATED in 1 PACKAGE (49483-620-10) 49483-620-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-620-50) 49483-620-81 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-620-81)

Ingredients (1)

metformin hydrochloride (1000 mg/1)

Linked Drug Pages (1)

Metformin HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2dc48b61-581f-fe5c-e063-6394a90aa557", "openfda": {"upc": ["0349483622102", "0349483621013", "0349483621105", "0349483621815", "0349483622812", "0349483620818", "0349483622010", "0349483620016"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010"], "spl_set_id": ["542cec22-eeae-4704-9bb6-4176640e5ea8"], "manufacturer_name": ["TIME CAP LABORATORIES, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-620-01)", "package_ndc": "49483-620-01", "marketing_start_date": "20161116"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 PACKAGE (49483-620-10)", "package_ndc": "49483-620-10", "marketing_start_date": "20170605"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-620-50)", "package_ndc": "49483-620-50", "marketing_start_date": "20161116"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49483-620-81)", "package_ndc": "49483-620-81", "marketing_start_date": "20170605"}], "brand_name": "Metformin HCl", "product_id": "49483-620_2dc48b61-581f-fe5c-e063-6394a90aa557", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "49483-620", "generic_name": "Metformin HCl", "labeler_name": "TIME CAP LABORATORIES, INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin HCl", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA090888", "marketing_category": "ANDA", "marketing_start_date": "20161114", "listing_expiration_date": "20261231"}