What is NDC 71335-2568?

71335-2568 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 9 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-2568

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-2568Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-2568Add 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
71335-2568-1	7133525680171335256801	60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-1)Marketed from Feb 5, 2025
71335-2568-2	7133525680271335256802	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-2)Marketed from Feb 5, 2025
71335-2568-3	7133525680371335256803	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-3)Marketed from Feb 5, 2025
71335-2568-4	7133525680471335256804	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-4)Marketed from Feb 5, 2025
71335-2568-5	7133525680571335256805	120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-5)Marketed from Feb 5, 2025
71335-2568-6	7133525680671335256806	15 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-6)Marketed from Feb 5, 2025
71335-2568-7	7133525680771335256807	45 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-7)Marketed from Feb 5, 2025
71335-2568-8	7133525680871335256808	180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-8)Marketed from Feb 5, 2025
71335-2568-9	7133525680971335256809	20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2568-9)Marketed from Feb 5, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217631
Marketing start: Oct 6, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Biguanides (Chemical structure)
Identifiers: Product ID 71335-2568_b59e65e1-5676-4535-920b-88b8becefc10SPL ID b59e65e1-5676-4535-920b-88b8becefc10SPL set ID 4db5551b-04f6-4921-9dee-68acb41f7f71RxCUI 860975UNII 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

N471335256801 followed by a unit qualifier and the quantity

Package 71335-2568-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

About NDC 71335-2568

What is NDC 71335-2568?: 71335-2568 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 9 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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 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 500 mg/1	Tablet, Extended releaseOral	Laurus Labs Limited	42385-977
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	A-S Medication Solutions	50090-7576
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
Metformin Hydrochloride	Metformin hydrochloride 750 mg/1	Tablet, Extended releaseOral	Coupler LLC	67046-1556
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Redpharm Drug	67296-2305
Metformin Hydrochloride	Metformin hydrochloride 500 mg/1	Tablet, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-8866