NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8552Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8552Add 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
68788-8552-468788855204687888552041 TUBE in 1 CARTON (68788-8552-4) / 45 g in 1 TUBEMarketed from Nov 20, 2023

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 — 7.5 mg/g
Dosage form
Cream
Route
Topical
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217128
Marketing start
Listing expires
Other FDA classes
Nitroimidazoles (Chemical structure)
Identifiers
Product ID 68788-8552_1969dc9c-4ced-498b-90a6-c027846b7aafSPL ID 1969dc9c-4ced-498b-90a6-c027846b7aafSPL set ID 59e53582-244a-4e9d-b18e-75dddc6a5052RxCUI 311678UNII 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N468788855204 followed by a unit qualifier and the quantity

Package 68788-8552-04. 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 .

Indications (excerpt from the label)

INDICATIONS AND USAGE Metronidazole topical cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8552

What is NDC 68788-8552?
68788-8552 is the product NDC for Metronidazole, Metronidazole 7.5 mg/g cream, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 1 package NDC, 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 217128

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

FDA NDC Directory listings under ANDA 217128
ProductStrengthForm · routeLabelerProduct NDC
MetronidazoleMetronidazole 7.5 mg/gCreamTopicalZydus Lifesciences Limited70771-1834
MetronidazoleMetronidazole 7.5 mg/gCreamTopicalViona Pharmaceuticals Inc72578-129

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