NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2533Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2533Add 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
71335-2533-0713352533001000 TABLET, FILM COATED in 1 BOTTLE (71335-2533-0)Marketed from Dec 10, 2024
71335-2533-17133525330160 TABLET, FILM COATED in 1 BOTTLE (71335-2533-1)Marketed from Dec 10, 2024
71335-2533-271335253302100 TABLET, FILM COATED in 1 BOTTLE (71335-2533-2)Marketed from Dec 10, 2024
71335-2533-37133525330330 TABLET, FILM COATED in 1 BOTTLE (71335-2533-3)Marketed from Dec 10, 2024
71335-2533-471335253304120 TABLET, FILM COATED in 1 BOTTLE (71335-2533-4)Marketed from Dec 10, 2024
71335-2533-57133525330590 TABLET, FILM COATED in 1 BOTTLE (71335-2533-5)Marketed from Dec 10, 2024
71335-2533-67133525330628 TABLET, FILM COATED in 1 BOTTLE (71335-2533-6)Marketed from Dec 10, 2024
71335-2533-77133525330756 TABLET, FILM COATED in 1 BOTTLE (71335-2533-7)Marketed from Dec 10, 2024
71335-2533-871335253308180 TABLET, FILM COATED in 1 BOTTLE (71335-2533-8)Marketed from Dec 10, 2024

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 — 1000 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 209882
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 71335-2533_e56912bc-7e1f-4c23-a23e-2c0e094c6b2cSPL ID e56912bc-7e1f-4c23-a23e-2c0e094c6b2cSPL set ID 286d959a-51cb-4dbd-a3e8-1ea2f00b54c7RxCUI 861004UNII 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

N471335253300 followed by a unit qualifier and the quantity

Package 71335-2533-00. 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 tablets, USP 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 tablets, USP 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. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 209882

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

FDA NDC Directory listings under ANDA 209882
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8498
Metformin HCLMetformin hydrochloride 500 mg/1Tablet, Film coatedOralDirect_Rx72189-658
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7106
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7107
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8600
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-644
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6857
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6856
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-948
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6858
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-947
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6859
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-949
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2224
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralCoupler LLC67046-1594
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4262
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2593
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7866
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8756
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3833

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