NDC codes

FDA NDC Directory
Product NDC (as listed)68071-1419Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-1419Add 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
68071-1419-26807114190220 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-2)Marketed from Mar 29, 2017
68071-1419-36807114190330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-3)Marketed from Mar 29, 2017
68071-1419-66807114190660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-6)Marketed from Mar 29, 2017
68071-1419-868071141908180 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-8)Marketed from Mar 29, 2017
68071-1419-96807114190990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-9)Marketed from Mar 29, 2017

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 201991
Marketing start
Listing expires
Other FDA classes
Biguanides (Chemical structure)
Identifiers
Product ID 68071-1419_3f67ac3d-1505-3418-e063-6394a90a938fSPL ID 3f67ac3d-1505-3418-e063-6394a90a938fSPL set ID 4be72741-4f6d-6689-e054-00144ff8d46cRxCUI 1807917UNII 786Z46389EUPC 0368071141986
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

N468071141902 followed by a unit qualifier and the quantity

Package 68071-1419-02. 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)

INDICATIONS AND USAGE Metformin hydrochloride extended release tablets USP are 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)

Other NDCs under ANDA 201991

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

FDA NDC Directory listings under ANDA 201991
ProductStrengthForm · routeLabelerProduct NDC
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralQPharma Inc42708-201
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNorthwind Health Company, LLC51655-559
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAphena Pharma Solutions - Tennessee, LLC71610-837
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7116
Metformin Hydrochloride ERmetformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralLeading Pharma, LLC69315-410
Metformin hydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralProficient Rx LP63187-779
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-400
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8289
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8814
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralAscend Laboratories, LLC67877-159
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralPD-Rx Pharmaceuticals, Inc.72789-455
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-1494
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-7579
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-0886

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