Metformin Hydrochloride NDC 24658-791

NDC codes

FDA NDC Directory

Product NDC (as listed)24658-791Labeler and product segments. Claims need a package NDC.

Product NDC at billing width24658-0791Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
24658-791-05	24658079105	500 TABLET, FILM COATED in 1 BOTTLE (24658-791-05)Marketed from Apr 1, 2016

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Metformin Hydrochloride
Generic name (nonproprietary): metformin hydrochloride
Active ingredients: Metformin hydrochloride — 850 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: PuraCap Laboratories LLC dba Blu Pharmaceuticals
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075965
Marketing start: Apr 1, 2016
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 24658-791_7ea9ad08-6f32-ebc1-e053-2a91aa0a7adeSPL ID 7ea9ad08-6f32-ebc1-e053-2a91aa0a7adeSPL set ID 5c2581e3-2b30-4da5-8bed-228173ca20d2RxCUI 861004, 861007, 861010UNII 786Z46389EUPC 0324658792057, 0324658790015, 0324658791050
Pharmacologic class: Biguanide

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N424658079105 followed by a unit qualifier and the quantity

Package 24658-0791-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 4, 2019. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Metformin hydrochloride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults and children with type 2 diabetes mellitus. Metformin hydrochloride tablets USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075965

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075965
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coatedOral	PuraCap Laboratories LLC dba Blu Pharmaceuticals	24658-790
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	PuraCap Laboratories LLC dba Blu Pharmaceuticals	24658-792