NDC codes

FDA NDC Directory
Product NDC (as listed)71335-9752Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-9752Add 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 NDC11-digit (billing)PackageCopy
71335-9752-1713359752017133597520130 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9752-1)Marketed from Apr 5, 2024
71335-9752-2713359752027133597520290 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9752-2)Marketed from Apr 5, 2024
71335-9752-3713359752037133597520360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9752-3)Marketed from Apr 5, 2024
71335-9752-47133597520471335975204180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9752-4)Marketed from Apr 5, 2024
71335-9752-57133597520571335975205100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9752-5)Marketed from Jul 14, 2023

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 — 750 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 077078
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 71335-9752_1125a013-872f-4b83-9212-b29293abf871SPL ID 1125a013-872f-4b83-9212-b29293abf871SPL set ID 11d52559-bfde-4c2a-9602-f18fb3187617RxCUI 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

N471335975201 followed by a unit qualifier and the quantity

Package 71335-9752-01. 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 . 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 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)

About NDC 71335-9752

What is NDC 71335-9752?
71335-9752 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 750 mg/1 tablet, extended release, listed with the FDA by Bryant Ranch Prepack. It has 5 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478170518-4781-00
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralMarlex Pharmaceuticals, Inc.10135-82310135-0823-0510135-0823-1010135-0823-30+5 more
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralMarlex Pharmaceuticals, Inc.10135-82410135-0824-0510135-0824-1010135-0824-90
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-418568788-4185-0168788-4185-0368788-4185-06+3 more
Metformin HydrochlorideMetformin hydrochloride 625 mg/1TabletOralScieGen Pharmaceuticals Inc50228-58850228-0588-0550228-0588-30
Metformin HydrochlorideMetformin hydrochloride 750 mg/1TabletOralScieGen Pharmaceuticals Inc50228-58950228-0589-0550228-0589-30
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-471070518-4710-0070518-4710-02
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralREMEDYREPACK INC.70518-469870518-4698-00
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-059180425-0591-0180425-0591-0280425-0591-03+1 more
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralUnit Dose Solutions, Inc.87441-05487441-0054-01

All 367 Metformin Hydrochloride NDCs

Other NDCs under ANDA 077078

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

FDA NDC Directory listings under ANDA 077078
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralZydus Lifesciences Limited65841-039
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralViona Pharmaceuticals Inc72578-036

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