What is NDC 42385-977?

42385-977 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Laurus Labs Limited. It has 7 package NDCs, shown above in 10- and 11-digit form.

Laurus Labs Limited, NDC labeler code 42385. 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 42385-977 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)42385-977Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42385-0977Add 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
42385-977-01	42385097701	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-01)Marketed from Oct 6, 2023
42385-977-05	42385097705	500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-05)Marketed from Oct 6, 2023
42385-977-11	42385097711	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-11)Marketed from Oct 6, 2023
42385-977-18	42385097718	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-18)Marketed from Oct 6, 2023
42385-977-30	42385097730	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-30)Marketed from Oct 6, 2023
42385-977-72	42385097772	15 BLISTER PACK in 1 CARTON (42385-977-72) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Oct 6, 2023
42385-977-90	42385097790	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (42385-977-90)Marketed from Oct 6, 2023

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: Laurus Labs LimitedNDC labeler code 42385
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217631
Marketing start: Oct 6, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 42385-977_59e47cee-79d7-4adc-9a71-165c170e5006SPL ID 59e47cee-79d7-4adc-9a71-165c170e5006
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

N442385097701 followed by a unit qualifier and the quantity

Package 42385-0977-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 42385-977

What is NDC 42385-977?: 42385-977 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Laurus Labs Limited. It has 7 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?: Laurus Labs Limited, NDC labeler code 42385. 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 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
Metformin Hydrochloride	Metformin hydrochloride 1000 mg/1	Tablet, Extended releaseOral	REMEDYREPACK INC.	70518-4677	70518-4677-0070518-4677-01

All 367 Metformin Hydrochloride NDCs

Other NDCs under ANDA 217631

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

FDA NDC Directory listings under ANDA 217631
Product	Strength	Form · route	Labeler	Product NDC
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1556
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-8866
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Laurus Labs Limited	42385-978
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7534
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7535
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Redpharm Drug	67296-2305
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7576
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Bryant Ranch Prepack	71335-2568
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7577
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	A-S Medication Solutions	50090-7918