NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2354Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2354Add 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
71335-2354-1713352354017133523540160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-1)Marketed from May 22, 2024
71335-2354-2713352354027133523540230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-2)Marketed from May 24, 2024
71335-2354-37133523540371335235403100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-3)Marketed from Mar 12, 2024
71335-2354-4713352354047133523540490 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-4)Marketed from Feb 7, 2024
71335-2354-57133523540571335235405120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-5)Marketed from Apr 11, 2024
71335-2354-6713352354067133523540615 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-6)Marketed from Apr 2, 2024
71335-2354-7713352354077133523540745 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-7)Marketed from Aug 26, 2024
71335-2354-87133523540871335235408180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-8)Marketed from Aug 26, 2024
71335-2354-9713352354097133523540920 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2354-9)Marketed from Aug 26, 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
Generic name (nonproprietary)
metformin er 500 mg
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 209313
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 71335-2354_79d66c47-1f73-460c-b21a-752d2a8155daSPL ID 79d66c47-1f73-460c-b21a-752d2a8155daSPL set ID 1f823d36-c7a6-4cf8-b6f1-52b7a51c8fc4RxCUI 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

N471335235401 followed by a unit qualifier and the quantity

Package 71335-2354-01. 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 .

Indications (excerpt from the label)

INDICATIONS & USAGE Metformin hydrochloride extended-release tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2354

What is NDC 71335-2354?
71335-2354 is the product NDC for Metformin (metformin er 500 mg), 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 (Metformin ER 500 mg).
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?
18 other product NDCs are listed under this name. See all Metformin 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralCoupler LLC67046-043767046-0437-03
MetforminMetformin hydrochloride 1000 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-465170518-4651-00
MetforminMetformin hydrochloride 1000 mg/1Tablet, Extended releaseOralCoupler LLC67046-158467046-1584-03
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-437070518-4370-0070518-4370-0170518-4370-03+1 more
MetforminMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralCoupler LLC67046-155767046-1557-03
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralLegacy Pharmaceutical Packaging, LLC68645-59568645-0595-59
MetforminMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-63350742-0633-1050742-0633-6050742-0633-90
MetforminMetformin hydrochloride 1000 mg/1Tablet, Extended releaseOralIngenus Pharmaceuticals, LLC50742-63450742-0634-1050742-0634-3050742-0634-60
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-651550090-6515-0050090-6515-0150090-6515-02+2 more
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-651650090-6516-00

All 19 Metformin NDCs

Other NDCs under ANDA 209313

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

FDA NDC Directory listings under ANDA 209313
ProductStrengthForm · routeLabelerProduct NDC
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-6515
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-6516
Metforminmetformin er 750 mgMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7372
Metforminmetformin er 750 mgMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7373
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralCoupler LLC67046-0437
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralLegacy Pharmaceutical Packaging, LLC68645-595
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralGranules Pharmaceuticals Inc.70010-491
Metforminmetformin er 750 mgMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralGranules Pharmaceuticals Inc.70010-492
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4370
Metforminmetformin er 750 mgMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2524
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-613
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-2424
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP82804-147
Metformin ER 500 mgMetformin hydrochloride 500 mg/1TabletOralGranules India Ltd62207-491
Metformin ER 500 mgMetformin hydrochloride 500 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-117
Metformin ER 750 mgMetformin hydrochloride 750 mg/1TabletOralGranules India Ltd62207-492
Metformin ER 750 mgMetformin hydrochloride 750 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-118

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