metformin hydrochloride

Generic: metformin hydrochloride

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-306
Product ID 47335-306_33ab529d-b535-4138-9c3d-dbde05d702c9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202917
Listing Expiration 2026-12-31
Marketing Start 2018-05-22

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335306
Hyphenated Format 47335-306

Supplemental Identifiers

RxCUI
1807888 1807915
UPC
0347335305883
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 ANDA202917 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-18)
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-81)
  • 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-83)
  • 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-88)
source: ndc

Packages (4)

47335-306-18 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-18) 47335-306-81 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-81) 47335-306-83 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-83) 47335-306-88 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-88)

Ingredients (1)

metformin hydrochloride (1000 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": "33ab529d-b535-4138-9c3d-dbde05d702c9", "openfda": {"upc": ["0347335305883"], "unii": ["786Z46389E"], "rxcui": ["1807888", "1807915"], "spl_set_id": ["52c18b5c-2322-4b22-a36e-3c573d609dd0"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-18)", "package_ndc": "47335-306-18", "marketing_start_date": "20180522"}, {"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-81)", "package_ndc": "47335-306-81", "marketing_start_date": "20190722"}, {"sample": false, "description": "30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-83)", "package_ndc": "47335-306-83", "marketing_start_date": "20180522"}, {"sample": false, "description": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-306-88)", "package_ndc": "47335-306-88", "marketing_start_date": "20180522"}], "brand_name": "Metformin Hydrochloride", "product_id": "47335-306_33ab529d-b535-4138-9c3d-dbde05d702c9", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "47335-306", "generic_name": "Metformin Hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA202917", "marketing_category": "ANDA", "marketing_start_date": "20180522", "listing_expiration_date": "20261231"}