NDC codes

FDA NDC Directory
Product NDC (as listed)62207-491Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62207-0491Add 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
62207-491-3162207049131622070491315000 TABLET in 1 POUCH (62207-491-31)Marketed from Jun 28, 2018
62207-491-35622070491356220704913525000 TABLET in 1 CARTON (62207-491-35)Marketed from Jun 28, 2018
62207-491-436220704914362207049143100 TABLET in 1 BOTTLE (62207-491-43)Marketed from Jul 25, 2019
62207-491-476220704914762207049147500 TABLET in 1 BOTTLE (62207-491-47)Marketed from Jul 25, 2019
62207-491-4962207049149622070491491000 TABLET in 1 BOTTLE (62207-491-49)Marketed from Jul 25, 2019
62207-491-54622070491546220704915430 TABLET in 1 BOTTLE (62207-491-54)Marketed from Jul 25, 2019

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 ER 500 mg
Generic name (nonproprietary)
metformin er 500 mg
Active ingredients
Metformin hydrochloride — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Granules India LtdNDC labeler code 62207
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 62207-491_56cbdf81-acdf-940c-e063-6394a90ad166SPL ID 56cbdf81-acdf-940c-e063-6394a90ad166SPL set ID b857eccf-b9ff-45ba-8241-f47f5caada2aRxCUI 860975, 860981UNII 786Z46389EUPC 0362207491549
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

N462207049131 followed by a unit qualifier and the quantity

Package 62207-0491-31. 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62207-491

What is NDC 62207-491?
62207-491 is the product NDC for Metformin ER 500 mg, Metformin hydrochloride 500 mg/1 tablet, listed with the FDA by Granules India Ltd. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Metformin ER 500 mg.
What is the active ingredient?
Metformin hydrochloride.
Who is the labeler?
Granules India Ltd, NDC labeler code 62207. 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 ER 500 mg?
1 other product NDC are listed under this name. See all Metformin ER 500 mg 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 ER 500 mg NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Metformin ER 500 mgMetformin hydrochloride 500 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-11782009-0117-10

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 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2354
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/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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