metformin hydrochloride

Generic: metformin hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride
Generic Name metformin hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metformin hydrochloride 1000 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-544
Product ID 43063-544_413942f3-9d8b-ea87-e063-6394a90aeb7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077880
Listing Expiration 2026-12-31
Marketing Start 2012-12-17

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063544
Hyphenated Format 43063-544

Supplemental Identifiers

RxCUI
861004
UPC
0343063544303
UNII
786Z46389E

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 ANDA077880 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1000 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (43063-544-30)
  • 60 TABLET in 1 BOTTLE, PLASTIC (43063-544-60)
  • 90 TABLET in 1 BOTTLE, PLASTIC (43063-544-90)
  • 180 TABLET in 1 BOTTLE, PLASTIC (43063-544-93)
  • 120 TABLET in 1 BOTTLE, PLASTIC (43063-544-98)
source: ndc

Packages (5)

43063-544-30 30 TABLET in 1 BOTTLE, PLASTIC (43063-544-30) 43063-544-60 60 TABLET in 1 BOTTLE, PLASTIC (43063-544-60) 43063-544-90 90 TABLET in 1 BOTTLE, PLASTIC (43063-544-90) 43063-544-93 180 TABLET in 1 BOTTLE, PLASTIC (43063-544-93) 43063-544-98 120 TABLET in 1 BOTTLE, PLASTIC (43063-544-98)

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": "413942f3-9d8b-ea87-e063-6394a90aeb7f", "openfda": {"upc": ["0343063544303"], "unii": ["786Z46389E"], "rxcui": ["861004"], "spl_set_id": ["c72cfd1a-dce9-43a3-88e2-3cf1d9078b52"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (43063-544-30)", "package_ndc": "43063-544-30", "marketing_start_date": "20140403"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE, PLASTIC (43063-544-60)", "package_ndc": "43063-544-60", "marketing_start_date": "20140403"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (43063-544-90)", "package_ndc": "43063-544-90", "marketing_start_date": "20140403"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE, PLASTIC (43063-544-93)", "package_ndc": "43063-544-93", "marketing_start_date": "20140403"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (43063-544-98)", "package_ndc": "43063-544-98", "marketing_start_date": "20140403"}], "brand_name": "Metformin Hydrochloride", "product_id": "43063-544_413942f3-9d8b-ea87-e063-6394a90aeb7f", "dosage_form": "TABLET", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "43063-544", "generic_name": "Metformin Hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "1000 mg/1"}], "application_number": "ANDA077880", "marketing_category": "ANDA", "marketing_start_date": "20121217", "listing_expiration_date": "20261231"}