What is NDC 76385-128?

76385-128 is the product NDC for Metformin hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by UNICHEM PHARMACEUTICALS (USA), INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.

UNICHEM PHARMACEUTICALS (USA), INC., NDC labeler code 76385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Metformin hydrochloride?

366 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metformin hydrochloride NDC 76385-128

NDC codes

FDA NDC Directory

Product NDC (as listed)76385-128Labeler and product segments. Claims need a package NDC.

Product NDC at billing width76385-0128Add 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
76385-128-01	7638501280176385012801	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-01)Marketed from Jul 17, 2018
76385-128-10	7638501281076385012810	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-10)Marketed from Jul 17, 2018
76385-128-50	7638501285076385012850	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (76385-128-50)Marketed from Jul 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 — 500 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: UNICHEM PHARMACEUTICALS (USA), INC.NDC labeler code 76385
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207427
Marketing start: Jul 17, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 76385-128_ffb50294-b2b1-46ed-a344-de6f6fef7406SPL ID ffb50294-b2b1-46ed-a344-de6f6fef7406SPL set ID 93c8deae-3103-4cbf-a5d1-fe0d37e76df8RxCUI 860975, 860981UNII 786Z46389E
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

N476385012801 followed by a unit qualifier and the quantity

Package 76385-0128-01. 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 May 11, 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 and pediatric patients 10 years of age and older 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 and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76385-128

What is NDC 76385-128?: 76385-128 is the product NDC for Metformin hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by UNICHEM PHARMACEUTICALS (USA), INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Metformin hydrochloride.
What is the active ingredient?: Metformin hydrochloride.
Who is the labeler?: UNICHEM PHARMACEUTICALS (USA), INC., NDC labeler code 76385. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Metformin hydrochloride?: 366 other product NDCs are listed under this name. See all Metformin hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Metformin hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4781	70518-4781-00
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-823	10135-0823-0510135-0823-1010135-0823-30+5 more
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Marlex Pharmaceuticals, Inc.	10135-824	10135-0824-0510135-0824-1010135-0824-90
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4185	68788-4185-0168788-4185-0368788-4185-06+3 more
Metformin Hydrochloride	Metformin hydrochloride 625 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-588	50228-0588-0550228-0588-30
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	TabletOral	ScieGen Pharmaceuticals Inc	50228-589	50228-0589-0550228-0589-30
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4710	70518-4710-0070518-4710-02
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	TabletOral	REMEDYREPACK INC.	70518-4698	70518-4698-00
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Film coatedOral	Advanced Rx of Tennessee, LLC	80425-0591	80425-0591-0180425-0591-0280425-0591-03+1 more
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	TabletOral	Unit Dose Solutions, Inc.	87441-054	87441-0054-01

All 367 Metformin hydrochloride NDCs

Other NDCs under ANDA 207427

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

FDA NDC Directory listings under ANDA 207427
Product	Strength	Form · route	Labeler	Product NDC
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-587
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-858
Metformin hydrochloride ERmetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-867
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-105
Metformin hydrochloride ERmetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	PD-Rx Pharmaceuticals, Inc.	72789-106
Metformin hydrochloride ERmetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-666
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	AvKARE	42291-825
Metformin hydrochloride ERmetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	AvKARE	42291-824
Metformin hydrochloride ERmetformin hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	UNICHEM PHARMACEUTICALS (USA), INC.	76385-129
Metformin hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Aphena Pharma Solutions - Tennessee, LLC	71610-554