NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2224Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2224Add 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
71335-2224-0713352224007133522240025 TABLET, FILM COATED in 1 BOTTLE (71335-2224-0)Marketed from Apr 3, 2024
71335-2224-1713352224017133522240130 TABLET, FILM COATED in 1 BOTTLE (71335-2224-1)Marketed from Aug 29, 2023
71335-2224-2713352224027133522240260 TABLET, FILM COATED in 1 BOTTLE (71335-2224-2)Marketed from Sep 20, 2023
71335-2224-37133522240371335222403100 TABLET, FILM COATED in 1 BOTTLE (71335-2224-3)Marketed from Nov 16, 2023
71335-2224-47133522240471335222404120 TABLET, FILM COATED in 1 BOTTLE (71335-2224-4)Marketed from Apr 3, 2024
71335-2224-5713352224057133522240590 TABLET, FILM COATED in 1 BOTTLE (71335-2224-5)Marketed from Apr 3, 2024
71335-2224-6713352224067133522240628 TABLET, FILM COATED in 1 BOTTLE (71335-2224-6)Marketed from Apr 3, 2024
71335-2224-7713352224077133522240756 TABLET, FILM COATED in 1 BOTTLE (71335-2224-7)Marketed from Apr 3, 2024
71335-2224-87133522240871335222408180 TABLET, FILM COATED in 1 BOTTLE (71335-2224-8)Marketed from Sep 18, 2023
71335-2224-9713352224097133522240910 TABLET, FILM COATED in 1 BOTTLE (71335-2224-9)Marketed from Apr 3, 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 — 500 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-2224_d2fb4e01-5d2e-483d-92eb-97f654fd9fe8SPL ID d2fb4e01-5d2e-483d-92eb-97f654fd9fe8SPL set ID ed6e6f87-ddd7-4c9d-a263-47154d3a9478RxCUI 861007UNII 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

N471335222400 followed by a unit qualifier and the quantity

Package 71335-2224-00. 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)

About NDC 71335-2224

What is NDC 71335-2224?
71335-2224 is the product NDC for Metformin Hydrochloride, Metformin hydrochloride 500 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 10 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 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 coatedOralCoupler LLC67046-1594
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 1000 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2533
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3833
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-949
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8498
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-947
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralLaurus Labs Limited42385-948
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7107
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7106
Metformin HydrochlorideMetformin hydrochloride 850 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2593
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4262
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6859
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6856
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6857
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-6858
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8600
Metformin HCLMetformin hydrochloride 500 mg/1Tablet, Film coatedOralDirect_Rx72189-658
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-644

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