Prescription drug · ANDA

Metformin Hydrochloride NDC 71335-0720

Metformin hydrochloride 500 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0720Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0720Add 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
71335-0720-17133507200160 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0720-1)Marketed from Mar 15, 2018
71335-0720-27133507200230 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0720-2)Marketed from Mar 15, 2018
71335-0720-371335072003100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0720-3)Marketed from Mar 15, 2018
71335-0720-47133507200490 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0720-4)Marketed from Mar 15, 2018
71335-0720-571335072005120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0720-5)Marketed from Mar 15, 2018
71335-0720-67133507200615 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0720-6)Marketed from Mar 15, 2018
71335-0720-77133507200745 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0720-7)Marketed from Mar 15, 2018
71335-0720-871335072008180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0720-8)Marketed from Mar 15, 2018
71335-0720-97133507200920 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-0720-9)Marketed from Mar 15, 2018

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 Hydrochloride
Generic name (nonproprietary)
metformin hydrochloride
Active ingredients
Metformin hydrochloride — 500 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
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 71335-0720_17b869c0-6c85-4436-a3f1-2b411c2f3367SPL ID 17b869c0-6c85-4436-a3f1-2b411c2f3367SPL set ID de4a660b-172b-4c72-9e38-5634fd03cfa7RxCUI 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

N471335072001 followed by a unit qualifier and the quantity

Package 71335-0720-01. 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 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 750 mg/1Tablet, Extended releaseOralTAGI Pharma, Inc.51224-107
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 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 71335-0720 | Med-Code