NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2399Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2399Add 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
68071-2399-468071239904680712399044 TABLET in 1 BOTTLE (68071-2399-4)Marketed from May 12, 2021
68071-2399-668071239906680712399066 TABLET in 1 BOTTLE (68071-2399-6)Marketed from May 12, 2021

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)
Metronidazole
Generic name (nonproprietary)
metronidazole
Active ingredients
Metronidazole — 500 mg/1
Dosage form
Tablet
Route
Oral
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203974
Marketing start
Listing expires
Other FDA classes
Nitroimidazoles (Chemical structure)
Identifiers
Product ID 68071-2399_4cecacbc-1f33-c0b5-e063-6394a90aeb33SPL ID 4cecacbc-1f33-c0b5-e063-6394a90aeb33SPL set ID c225a455-ec25-2213-e053-2995a90a3389RxCUI 311681UNII 140QMO216EUPC 0368071239942
Pharmacologic class
Nitroimidazole Antimicrobial

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

N468071239904 followed by a unit qualifier and the quantity

Package 68071-2399-04. 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 Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite. Treatme…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-2399

What is NDC 68071-2399?
68071-2399 is the product NDC for Metronidazole, Metronidazole 500 mg/1 tablet, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Metronidazole.
What is the active ingredient?
Metronidazole.
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 Metronidazole?
160 other product NDCs are listed under this name. See all Metronidazole 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 Metronidazole NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MetronidazoleMetronidazole 500 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-476770518-4767-00
MetronidazoleMetronidazole 250 mg/1Tablet, Film coatedOralKanchan Healthcare Inc85742-02485742-0024-2485742-0024-25
MetronidazoleMetronidazole 500 mg/1Tablet, Film coatedOralKanchan Healthcare Inc85742-02585742-0025-2485742-0025-25
MetronidazoleMetronidazole 250 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-267772162-2677-0172162-2677-0272162-2677-05
MetronidazoleMetronidazole 500 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-267872162-2678-0172162-2678-0272162-2678-05
MetronidazoleMetronidazole 500 mg/1Tablet, Film coatedOralCoupler LLC67046-106067046-1060-03
MetronidazoleMetronidazole 500 mg/1Tablet, Film coatedOralCoupler LLC67046-117367046-1173-03
MetronidazoleMetronidazole 7.5 mg/gGelTopicalZydus Lifesciences Limited70771-197870771-1978-04
MetronidazoleMetronidazole 7.5 mg/gGelTopicalViona Pharmaceuticals Inc72578-20972578-0209-04
MetronidazoleMetronidazole 7.5 mg/gGelVaginalSolaris Pharma Corporation73473-30373473-0303-70

All 161 Metronidazole NDCs

Other NDCs under ANDA 203974

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

FDA NDC Directory listings under ANDA 203974
ProductStrengthForm · routeLabelerProduct NDC
MetronidazoleMetronidazole 500 mg/1TabletOralRising Pharma Holdings, Inc.16571-664
MetronidazoleMetronidazole 250 mg/1TabletOralRising Pharma Holdings, Inc.16571-665
MetronidazoleMetronidazole 250 mg/1TabletOralA-S Medication Solutions50090-5691
MetronidazoleMetronidazole 250 mg/1TabletOralAurobindo Pharma Limited65862-694
MetronidazoleMetronidazole 500 mg/1TabletOralAurobindo Pharma Limited65862-695
MetronidazoleMetronidazole 500 mg/1TabletOralREMEDYREPACK INC.70518-3110
MetronidazoleMetronidazole 250 mg/1TabletOralBryant Ranch Prepack71335-1838
MetronidazoleMetronidazole 500 mg/1TabletOralBryant Ranch Prepack71335-1922

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