metformin hydrochloride

Generic: metformin hydrochloride extended-release tablets

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

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride extended-release tablets
Labeler aiping pharmaceutical, inc.
Dosage Form TABLET, FILM COATED, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
AiPing Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 11788-038
Product ID 11788-038_5ad15c75-5a99-4fa0-96f8-21e75064eff3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209993
Listing Expiration 2027-12-31
Marketing Start 2025-12-15

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11788038
Hyphenated Format 11788-038

Supplemental Identifiers

RxCUI
1807894 1807917
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 extended-release tablets (source: ndc)
Application Number ANDA209993 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (11788-038-60)
source: ndc

Packages (1)

11788-038-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (11788-038-60)

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": "5ad15c75-5a99-4fa0-96f8-21e75064eff3", "openfda": {"unii": ["786Z46389E"], "rxcui": ["1807894", "1807917"], "spl_set_id": ["96c8a89d-99db-24b1-e053-2a95a90ac2b8"], "manufacturer_name": ["AiPing Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (11788-038-60)", "package_ndc": "11788-038-60", "marketing_start_date": "20251215"}], "brand_name": "Metformin Hydrochloride", "product_id": "11788-038_5ad15c75-5a99-4fa0-96f8-21e75064eff3", "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "11788-038", "generic_name": "Metformin Hydrochloride Extended-Release Tablets", "labeler_name": "AiPing Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA209993", "marketing_category": "ANDA", "marketing_start_date": "20251215", "listing_expiration_date": "20271231"}