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
68071-1419-2680711419026807114190220 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-2)Marketed from Mar 29, 2017
68071-1419-3680711419036807114190330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-3)Marketed from Mar 29, 2017
68071-1419-6680711419066807114190660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-6)Marketed from Mar 29, 2017
68071-1419-86807114190868071141908180 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-1419-8)Marketed from Mar 29, 2017
68071-1419-9680711419096807114190990 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
Labeler
NuCare Pharmaceuticals, Inc.NDC labeler code 68071
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)

About NDC 68071-1419

What is NDC 68071-1419?
68071-1419 is the product NDC for Metformin hydrochloride, Metformin hydrochloride 500 mg/1 tablet, extended release, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Metformin hydrochloride.
What is the active ingredient?
Metformin hydrochloride.
Who is the labeler?
NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 hydrochloride?
366 other product NDCs are listed under this name. See all Metformin hydrochloride 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 hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-478170518-4781-00
Metformin HydrochlorideMetformin hydrochloride 500 mg/1Tablet, Extended releaseOralMarlex Pharmaceuticals, Inc.10135-82310135-0823-0510135-0823-1010135-0823-30+5 more
Metformin HydrochlorideMetformin hydrochloride 750 mg/1Tablet, Extended releaseOralMarlex Pharmaceuticals, Inc.10135-82410135-0824-0510135-0824-1010135-0824-90
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-418568788-4185-0168788-4185-0368788-4185-06+3 more
Metformin HydrochlorideMetformin hydrochloride 625 mg/1TabletOralScieGen Pharmaceuticals Inc50228-58850228-0588-0550228-0588-30
Metformin HydrochlorideMetformin hydrochloride 750 mg/1TabletOralScieGen Pharmaceuticals Inc50228-58950228-0589-0550228-0589-30
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Extended releaseOralREMEDYREPACK INC.70518-471070518-4710-0070518-4710-02
Metformin HydrochlorideMetformin hydrochloride 500 mg/1TabletOralREMEDYREPACK INC.70518-469870518-4698-00
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-059180425-0591-0180425-0591-0280425-0591-03+1 more
Metformin HydrochlorideMetformin hydrochloride 1000 mg/1TabletOralUnit Dose Solutions, Inc.87441-05487441-0054-01

All 367 Metformin hydrochloride NDCs

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

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