metformin hydrochloride oral solution

Generic: metformin hydrochloride

Labeler: saptalis pharmaceuticals, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metformin hydrochloride oral solution
Generic Name metformin hydrochloride
Labeler saptalis pharmaceuticals, llc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

metformin hydrochloride 500 mg/5mL

Manufacturer
Saptalis Pharmaceuticals, LLC.

Identifiers & Regulatory

Product NDC 71656-017
Product ID 71656-017_29f72dd3-74fc-29f4-e063-6294a90a4755
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211309
Listing Expiration 2026-12-31
Marketing Start 2024-07-31

Pharmacologic Class

Classes
biguanide [epc] biguanides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71656017
Hyphenated Format 71656-017

Supplemental Identifiers

RxCUI
861025
UPC
0371656017040
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 oral solution (source: ndc)
Generic Name metformin hydrochloride (source: ndc)
Application Number ANDA211309 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/5mL
source: ndc
Packaging
  • 118 mL in 1 BOTTLE (71656-017-04)
source: ndc

Packages (1)

71656-017-04 118 mL in 1 BOTTLE (71656-017-04)

Ingredients (1)

metformin hydrochloride (500 mg/5mL)

Linked Drug Pages (1)

Metformin Hydrochloride Oral Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "29f72dd3-74fc-29f4-e063-6294a90a4755", "openfda": {"upc": ["0371656017040"], "unii": ["786Z46389E"], "rxcui": ["861025"], "spl_set_id": ["df61d56e-18ff-404c-b671-42b39aa23574"], "manufacturer_name": ["Saptalis Pharmaceuticals, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (71656-017-04)", "package_ndc": "71656-017-04", "marketing_start_date": "20240731"}], "brand_name": "Metformin Hydrochloride Oral Solution", "product_id": "71656-017_29f72dd3-74fc-29f4-e063-6294a90a4755", "dosage_form": "SOLUTION", "pharm_class": ["Biguanide [EPC]", "Biguanides [CS]"], "product_ndc": "71656-017", "generic_name": "Metformin Hydrochloride", "labeler_name": "Saptalis Pharmaceuticals, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metformin Hydrochloride Oral Solution", "active_ingredients": [{"name": "METFORMIN HYDROCHLORIDE", "strength": "500 mg/5mL"}], "application_number": "ANDA211309", "marketing_category": "ANDA", "marketing_start_date": "20240731", "listing_expiration_date": "20261231"}