metformin hydrochloride

Generic: metformin hydrochloride

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler chartwell rx, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 625 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-681
Product ID 62135-681_0782ae1c-d904-d465-e063-6294a90a6676
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075972
Listing Expiration 2026-12-31
Marketing Start 2002-01-24

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135681
Hyphenated Format 62135-681

Supplemental Identifiers

RxCUI
861004 861007 861010 861021 2703582
UPC
0362135684051 0362135681302 0362135682309 0362135680053 0362135684907 0362135683184 0362135680183 0362135680909 0362135683306 0362135684181 0362135683900
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 (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA075972 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 625 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (62135-681-05)
  • 30 TABLET in 1 BOTTLE (62135-681-30)
  • 90 TABLET in 1 BOTTLE (62135-681-90)
source: ndc

Packages (3)

62135-681-05 500 TABLET in 1 BOTTLE (62135-681-05) 62135-681-30 30 TABLET in 1 BOTTLE (62135-681-30) 62135-681-90 90 TABLET in 1 BOTTLE (62135-681-90)

Ingredients (1)

metformin hydrochloride (625 mg/1)

Linked Drug Pages (1)

Metformin Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0782ae1c-d904-d465-e063-6294a90a6676", "openfda": {"upc": ["0362135684051", "0362135681302", "0362135682309", "0362135680053", "0362135684907", "0362135683184", "0362135680183", "0362135680909", "0362135683306", "0362135684181", "0362135683900"], "unii": ["786Z46389E"], "rxcui": ["861004", "861007", "861010", "861021", "2703582"], "spl_set_id": ["4d3dbf6f-1c8a-4daa-8343-8cd8f64a65cd"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (62135-681-05)", "package_ndc": "62135-681-05", "marketing_start_date": "20220406"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (62135-681-30)", "package_ndc": "62135-681-30", "marketing_start_date": "20220406"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (62135-681-90)", "package_ndc": "62135-681-90", "marketing_start_date": "20220406"}], "brand_name": "Metformin Hydrochloride", "product_id": "62135-681_0782ae1c-d904-d465-e063-6294a90a6676", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "62135-681", "generic_name": "Metformin Hydrochloride", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "625 mg/1"}], "application_number": "ANDA075972", "marketing_category": "ANDA", "marketing_start_date": "20020124", "listing_expiration_date": "20261231"}