metformin hydrochloride extended release

Generic: metformin hydrochloride

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

Drug Facts

Product Profile

Brand Name metformin hydrochloride extended release
Generic Name metformin hydrochloride
Labeler time cap laboratories, inc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/1

Manufacturer
TIME CAP LABORATORIES, INC

Identifiers & Regulatory

Product NDC 49483-623
Product ID 49483-623_2dc7c971-b13d-eb27-e063-6294a90a5cd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090295
Listing Expiration 2026-12-31
Marketing Start 2016-05-12

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49483623
Hyphenated Format 49483-623

Supplemental Identifiers

RxCUI
860975 860981
UPC
0349483624014 0349483623109 0349483623017
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 hydrochloride extended release (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA090295 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-01)
  • 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-09)
  • 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-10)
  • 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-50)
source: ndc

Packages (4)

49483-623-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-01) 49483-623-09 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-09) 49483-623-10 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-10) 49483-623-50 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-50)

Ingredients (1)

metformin hydrochloride (500 mg/1)

Linked Drug Pages (1)

METFORMIN HYDROCHLORIDE EXTENDED RELEASE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2dc7c971-b13d-eb27-e063-6294a90a5cd1", "openfda": {"upc": ["0349483624014", "0349483623109", "0349483623017"], "unii": ["786Z46389E"], "rxcui": ["860975", "860981"], "spl_set_id": ["1d8b8970-c2a1-4780-be87-ab8ccfd401fa"], "manufacturer_name": ["TIME CAP LABORATORIES, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-01)", "package_ndc": "49483-623-01", "marketing_start_date": "20160628"}, {"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-09)", "package_ndc": "49483-623-09", "marketing_start_date": "20170605"}, {"sample": false, "description": "1000 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-10)", "package_ndc": "49483-623-10", "marketing_start_date": "20170605"}, {"sample": false, "description": "500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-623-50)", "package_ndc": "49483-623-50", "marketing_start_date": "20160628"}], "brand_name": "METFORMIN HYDROCHLORIDE EXTENDED RELEASE", "product_id": "49483-623_2dc7c971-b13d-eb27-e063-6294a90a5cd1", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "49483-623", "generic_name": "Metformin Hydrochloride", "labeler_name": "TIME CAP LABORATORIES, INC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "METFORMIN HYDROCHLORIDE EXTENDED RELEASE", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA090295", "marketing_category": "ANDA", "marketing_start_date": "20160512", "listing_expiration_date": "20261231"}