Metformin Hydrochloride NDC 68462-521

NDC codes

FDA NDC Directory

Product NDC (as listed)68462-521Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68462-0521Add 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
68462-521-01	68462052101	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-01)Marketed from Nov 25, 2019
68462-521-05	68462052105	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-05)Marketed from Nov 25, 2019
68462-521-90	68462052190	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68462-521-90)Marketed from Nov 25, 2019

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 — 1000 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: GLENMARK PHARMACEUTICALS INC., USA
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212969
Marketing start: Nov 25, 2019
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 68462-521_75378e1b-a55d-48ee-9a0a-cd82d2fb78a0SPL ID 75378e1b-a55d-48ee-9a0a-cd82d2fb78a0SPL set ID 0ef9de1a-b786-4b6c-a250-3f5ac532b16aRxCUI 1807888, 1807915UNII 786Z46389EUPC 0368462521908, 0368462520017
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

N468462052101 followed by a unit qualifier and the quantity

Package 68462-0521-01. 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 31, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Metformin hydrochloride extended-release tablets are a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212969

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

FDA NDC Directory listings under ANDA 212969
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Film coated, Extended releaseOral	GLENMARK PHARMACEUTICALS INC., USA	68462-520