Prescription drug · ANDA

Metformin (Metformin er 500 mg) NDC 70518-4370

Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4370Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4370Add 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
70518-4370-0705184370007051843700030 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4370-0)Marketed from Jun 24, 2025
70518-4370-17051843700170518437001100 POUCH in 1 BOX (70518-4370-1) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4370-2)Marketed from Jun 24, 2025
70518-4370-3705184370037051843700390 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-3)Marketed from Jul 21, 2025
70518-4370-47051843700470518437004180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4370-4)Marketed from Aug 22, 2025

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
REMEDYREPACK INC.NDC labeler code 70518
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 70518-4370_5b0d17ff-e1b6-c6cf-e063-6394a90ae215SPL ID 5b0d17ff-e1b6-c6cf-e063-6394a90ae215SPL set ID 05999192-ebc6-4198-bd1e-f46abbfb4f8aRxCUI 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

N470518437000 followed by a unit qualifier and the quantity

Package 70518-4370-00. 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 extended-release tablets 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 extended-release tablets are 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 70518-4370

What is NDC 70518-4370?
70518-4370 is the product NDC for Metformin (metformin er 500 mg), Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by REMEDYREPACK INC.. It has 4 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?
REMEDYREPACK INC., NDC labeler code 70518. 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 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
Metforminmetformin er 750 mgMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-737250090-7372-0050090-7372-0150090-7372-02+1 more

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 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/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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