metformin hydrochloride

Generic: metformin hydrochloride

Labeler: oceanside pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler oceanside pharmaceuticals
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
Oceanside Pharmaceuticals

Identifiers & Regulatory

Product NDC 68682-018
Product ID 68682-018_26e1cf7e-cc48-cc39-e063-6394a90a62cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021748
Listing Expiration 2026-12-31
Marketing Start 2008-06-17

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68682018
Hyphenated Format 68682-018

Supplemental Identifiers

RxCUI
1807888 1807915
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 NDA021748 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-018-90)
source: ndc

Packages (1)

68682-018-90 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-018-90)

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": "26e1cf7e-cc48-cc39-e063-6394a90a62cc", "openfda": {"unii": ["786Z46389E"], "rxcui": ["1807888", "1807915"], "spl_set_id": ["74d32a8a-c4c2-4dbb-b376-eea3f8fa64d7"], "manufacturer_name": ["Oceanside Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-018-90)", "package_ndc": "68682-018-90", "marketing_start_date": "20080617"}], "brand_name": "Metformin hydrochloride", "product_id": "68682-018_26e1cf7e-cc48-cc39-e063-6394a90a62cc", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "68682-018", "generic_name": "metformin hydrochloride", "labeler_name": "Oceanside Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "NDA021748", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20080617", "listing_expiration_date": "20261231"}