Metronidazole NDC 68308-711

NDC codes

FDA NDC Directory

Product NDC (as listed)68308-711Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68308-0711Add 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 NDC	11-digit (billing)	Package	Copy
68308-711-45	68308071145	1 TUBE in 1 CARTON (68308-711-45) / 45 g in 1 TUBEMarketed from May 19, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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: Mayne Pharma Inc.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020531
Marketing start: May 19, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 68308-711_944575da-eb42-40dc-9dfe-8ee02bba38f1SPL ID 944575da-eb42-40dc-9dfe-8ee02bba38f1SPL set ID 567c7c0c-ffc1-47c1-b0fb-8715bf3d76b9RxCUI 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

N468308071145 followed by a unit qualifier and the quantity

Package 68308-0711-45. 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 Oct 31, 2024.

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)

Other NDCs under NDA 020531

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

FDA NDC Directory listings under NDA 020531
Product	Strength	Form · route	Labeler	Product NDC
Metronidazole	Metronidazole 7.5 mg/g	CreamTopical	Prasco Laboratories	66993-960