What is NDC 68308-663?

68308-663 is the product NDC for Metronidazole, Metronidazole 10 mg/g gel, listed with the FDA by Mayne Pharma Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Mayne Pharma Inc., NDC labeler code 68308. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Metronidazole NDC 68308-663 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68308-663Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68308-0663Add 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
68308-663-55	6830806635568308066355	1 BOTTLE, PUMP in 1 CARTON (68308-663-55) / 55 g in 1 BOTTLE, PUMPMarketed from Nov 10, 2023
68308-663-60	6830806636068308066360	1 TUBE in 1 CARTON (68308-663-60) / 60 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 — 10 mg/g
Dosage form: Gel
Route: Topical
Labeler: Mayne Pharma Inc.NDC labeler code 68308
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021789
Marketing start: Nov 10, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 68308-663_a5dc0ad6-1b71-45f9-b00b-cac2f5e2a26bSPL ID a5dc0ad6-1b71-45f9-b00b-cac2f5e2a26bSPL set ID 3c25a3f9-52fc-448e-a044-f63b9dadcd4aRxCUI 577237UNII 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

N468308066355 followed by a unit qualifier and the quantity

Package 68308-0663-55. 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)

Metronidazole Gel, 1% is indicated for the topical treatment of inflammatory lesions of rosacea. Metronidazole Gel, 1% is a nitroimidazole indicated for the topical treatment of inflammatory lesions of rosacea. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68308-663

What is NDC 68308-663?: 68308-663 is the product NDC for Metronidazole, Metronidazole 10 mg/g gel, listed with the FDA by Mayne Pharma 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?: Mayne Pharma Inc., NDC labeler code 68308. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4767	70518-4767-00
Metronidazole	Metronidazole 250 mg/1	Tablet, Film coatedOral	Kanchan Healthcare Inc	85742-024	85742-0024-2485742-0024-25
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Kanchan Healthcare Inc	85742-025	85742-0025-2485742-0025-25
Metronidazole	Metronidazole 250 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2677	72162-2677-0172162-2677-0272162-2677-05
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2678	72162-2678-0172162-2678-0272162-2678-05
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1060	67046-1060-03
Metronidazole	Metronidazole 500 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1173	67046-1173-03
Metronidazole	Metronidazole 7.5 mg/g	GelTopical	Zydus Lifesciences Limited	70771-1978	70771-1978-04
Metronidazole	Metronidazole 7.5 mg/g	GelTopical	Viona Pharmaceuticals Inc	72578-209	72578-0209-04
Metronidazole	Metronidazole 7.5 mg/g	GelVaginal	Solaris Pharma Corporation	73473-303	73473-0303-70

All 161 Metronidazole NDCs