Prescription drug · ANDA
Metronidazole NDC 46708-630
Metronidazole 10 mg/g · Gel · Topical · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-630-45 | 46708063045 | 1 TUBE in 1 CARTON (46708-630-45) / 45 g in 1 TUBEMarketed from Mar 17, 2025 | |
| 46708-630-55 | 46708063055 | 1 BOTTLE, PUMP in 1 CARTON (46708-630-55) / 55 g in 1 BOTTLE, PUMPMarketed from Mar 17, 2025 | |
| 46708-630-60 | 46708063060 | 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212646
- Marketing start
- Listing expires
- 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
N446708063045followed by a unit qualifier and the quantityPackage 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 .
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.
Other NDCs under ANDA 212646
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Metronidazole | Metronidazole 10 mg/g | GelTopical | Alembic Pharmaceuticals Inc. | 62332-630 |