NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7815Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7815Add 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
68788-7815-1687887815016878878150114 TABLET in 1 BOTTLE (68788-7815-1)Marketed from Nov 13, 2020
68788-7815-2687887815026878878150221 TABLET in 1 BOTTLE (68788-7815-2)Marketed from Nov 13, 2020
68788-7815-3687887815036878878150330 TABLET in 1 BOTTLE (68788-7815-3)Marketed from Nov 13, 2020
68788-7815-4687887815046878878150428 TABLET in 1 BOTTLE (68788-7815-4)Marketed from Nov 13, 2020
68788-7815-5687887815056878878150556 TABLET in 1 BOTTLE (68788-7815-5)Marketed from Nov 13, 2020
68788-7815-7687887815076878878150742 TABLET in 1 BOTTLE (68788-7815-7)Marketed from Nov 13, 2020

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
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206560
Marketing start
Listing expires
Other FDA classes
Nitroimidazoles (Chemical structure)
Identifiers
Product ID 68788-7815_1820c0da-b46b-409a-8e06-98acd1189737SPL ID 1820c0da-b46b-409a-8e06-98acd1189737SPL set ID ab695a3e-1721-491a-97a2-c3f617a8d9fcRxCUI 311681UNII 140QMO216E
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

N468788781501 followed by a unit qualifier and the quantity

Package 68788-7815-01. 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)

INDICATIONS AND USAGE Symptomatic Trichomoniasis. Metronidazole tablets, USP 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, USP 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 parasit…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-7815

What is NDC 68788-7815?
68788-7815 is the product NDC for metronidazole, Metronidazole 500 mg/1 tablet, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 6 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?
Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 206560

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

FDA NDC Directory listings under ANDA 206560
ProductStrengthForm · routeLabelerProduct NDC
metronidazoleMetronidazole 500 mg/1TabletOralBryant Ranch Prepack71335-1703
metronidazoleMetronidazole 250 mg/1TabletOralREMEDYREPACK INC.70518-3042
MetronidazoleMetronidazole 250 mg/1TabletOralZydus Lifesciences Limited70771-1045
metronidazoleMetronidazole 250 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-195
MetronidazoleMetronidazole 500 mg/1TabletOralZydus Lifesciences Limited70771-1046
metronidazoleMetronidazole 250 mg/1TabletOralBryant Ranch Prepack71335-1775
metronidazoleMetronidazole 500 mg/1TabletOralSportpharm LLC85766-024
metronidazoleMetronidazole 250 mg/1TabletOralViona Pharmaceuticals Inc72578-007
metronidazoleMetronidazole 500 mg/1TabletOralViona Pharmaceuticals Inc72578-008
metronidazoleMetronidazole 500 mg/1TabletOralBryant Ranch Prepack71335-2681
metronidazoleMetronidazole 500 mg/1TabletOralNorthwind Health Company, LLC82868-014
metronidazoleMetronidazole 250 mg/1TabletOralAsclemed USA, Inc.76420-800
metronidazoleMetronidazole 500 mg/1TabletOralAsclemed USA, Inc.76420-801
metronidazoleMetronidazole 500 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-2409
metronidazoleMetronidazole 500 mg/1TabletOralREMEDYREPACK INC.70518-2663
metronidazoleMetronidazole 500 mg/1TabletOralST. MARY'S MEDICAL PARK PHARMACY60760-539

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