Prescription drug · ANDA

Metformin ER 750 mg NDC 82009-118

Metformin hydrochloride 750 mg/1 · Tablet · Oral · Quallent Pharmaceuticals Health LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)82009-118Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82009-0118Add 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
82009-118-0182009011801100 TABLET in 1 BOTTLE (82009-118-01)Marketed from Jul 25, 2023

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 750 mg
Generic name (nonproprietary)
metformin er 750 mg
Active ingredients
Metformin hydrochloride — 750 mg/1
Dosage form
Tablet
Route
Oral
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 82009-118_451e9a75-128c-6b1d-e063-6394a90aa5d8SPL ID 451e9a75-128c-6b1d-e063-6394a90aa5d8SPL set ID ff196435-14f4-8b9d-e053-6294a90a4ee8RxCUI 860975, 860981UNII 786Z46389EUPC 0382009117102, 0382009118017
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

N482009011801 followed by a unit qualifier and the quantity

Package 82009-0118-01. 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 . 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 patients 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. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2354
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
Metformin ER 500 mgMetformin hydrochloride 500 mg/1TabletOralGranules India Ltd62207-491
Metformin ER 750 mgMetformin hydrochloride 750 mg/1TabletOralGranules India Ltd62207-492
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP82804-147
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralCoupler LLC67046-0437
Metformin ER 500 mgMetformin hydrochloride 500 mg/1TabletOralQuallent Pharmaceuticals Health LLC82009-117
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralLegacy Pharmaceutical Packaging, LLC68645-595
Metforminmetformin er 750 mgMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralGranules Pharmaceuticals Inc.70010-492
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-613
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralGranules Pharmaceuticals Inc.70010-491
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-6516
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1TabletOralA-S Medication Solutions50090-6515
Metforminmetformin er 750 mgMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2524
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-4370
Metforminmetformin er 500 mgMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack72162-2424

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Metformin ER 750 mg NDC 82009-118 | Med-Code