What is NDC 46708-630?

46708-630 is the product NDC for Metronidazole, Metronidazole 10 mg/g gel, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-630 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-630Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0630Add 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
46708-630-45	4670806304546708063045	1 TUBE in 1 CARTON (46708-630-45) / 45 g in 1 TUBEMarketed from Mar 17, 2025
46708-630-55	4670806305546708063055	1 BOTTLE, PUMP in 1 CARTON (46708-630-55) / 55 g in 1 BOTTLE, PUMPMarketed from Mar 17, 2025
46708-630-60	4670806306046708063060	1 TUBE in 1 CARTON (46708-630-60) / 60 g in 1 TUBEMarketed from Mar 17, 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: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212646
Marketing start: Mar 17, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Nitroimidazoles (Chemical structure)
Identifiers: Product ID 46708-630_ccb6c97f-34f9-4aeb-81ba-824a9b8a0ecdSPL ID ccb6c97f-34f9-4aeb-81ba-824a9b8a0ecdSPL set ID e43b880b-ce69-4f56-9c1c-9c7ca23bba84RxCUI 577237UNII 140QMO216EUPC 0346708630607
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

N446708063045 followed by a unit qualifier and the quantity

Package 46708-0630-45. 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 Mar 18, 2025.

Indications (excerpt from the label)

Metronidazole gel, 1% is nitroimidazole 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 46708-630

What is NDC 46708-630?: 46708-630 is the product NDC for Metronidazole, Metronidazole 10 mg/g gel, listed with the FDA by Alembic Pharmaceuticals Limited. It has 3 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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

Other NDCs under ANDA 212646

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

FDA NDC Directory listings under ANDA 212646
Product	Strength	Form · route	Labeler	Product NDC
Metronidazole	Metronidazole 10 mg/g	GelTopical	Alembic Pharmaceuticals Inc.	62332-630