Prescription drug · ANDA

Metformin Hydrochloride NDC 51224-107

Metformin hydrochloride 750 mg/1 · Tablet, Extended release · Oral · TAGI Pharma, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)51224-107Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51224-0107Add 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
51224-107-5051224010750100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-107-50)Marketed from Jun 1, 2016
51224-107-6051224010760500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51224-107-60)Marketed from Jun 1, 2016

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 Hydrochloride
Generic name (nonproprietary)
metformin hydrochloride
Active ingredients
Metformin hydrochloride — 750 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078321
Marketing start
Marketing end
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 51224-107_edb2d11c-e64f-4f34-9f13-98b4f9a834a2SPL ID edb2d11c-e64f-4f34-9f13-98b4f9a834a2SPL set ID dd0ee2bf-f658-42dc-976d-49af0b1f32b5RxCUI 860975, 860981UNII 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

N451224010750 followed by a unit qualifier and the quantity

Package 51224-0107-50. 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 a 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 078321

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

FDA NDC Directory listings under ANDA 078321
ProductStrengthForm · routeLabelerProduct NDC
Metformin Hydrochloride Extended-Release 500mgmetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralCalvin Scott & Co., Inc.17224-311
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-533
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-548
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAvPAK50268-550
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralAvPAK50268-551
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-7205
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOraldirect rx72189-150
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-3166
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP82804-195
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralProficient Rx LP71205-141
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralTAGI Pharma, Inc.51224-007
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8903
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP71205-186
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2504
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0720
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-454
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-451
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0776
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-2709
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralRedPharm Drug, Inc.67296-1701

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Metformin Hydrochloride NDC 51224-107 | Med-Code