Prescription drug · ANDA
Metronidazole Vaginal Gel (Metronidazole vaginal gel, 1.3 %) NDC 21922-046
Metronidazole 65 mg/5g · Gel · Vaginal · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-046-41 | 2192200464121922004641 | 1 APPLICATOR in 1 CARTON (21922-046-41) / 5 g in 1 APPLICATORMarketed from Mar 19, 2024 |
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 Vaginal Gel
- Generic name (nonproprietary)
- metronidazole vaginal gel, 1.3 %
- Active ingredients
- Metronidazole — 65 mg/5g
- Dosage form
- Gel
- Route
- Vaginal
- Labeler
- Encube Ethicals, Inc.NDC labeler code 21922
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216795
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 21922-046_fcf2dac3-2804-44d2-92ce-03c83220388cSPL ID fcf2dac3-2804-44d2-92ce-03c83220388cSPL set ID 585d2553-e19f-4227-82db-e4c2034863bfRxCUI 1608253UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N421922004641followed by a unit qualifier and the quantityPackage 21922-0046-41. 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 vaginal gel is indicated for the treatment of bacterial vaginosis in females 12 years of age and older. Metronidazole vaginal gel is a nitroimidazole antimicrobial indicated for the treatment of bacterial vaginosis in females 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 21922-046
- What is NDC 21922-046?
- 21922-046 is the product NDC for Metronidazole Vaginal Gel, Metronidazole 65 mg/5g gel, listed with the FDA by Encube Ethicals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metronidazole Vaginal Gel (Metronidazole vaginal gel, 1.3 %).
- What is the active ingredient?
- Metronidazole.
- Who is the labeler?
- Encube Ethicals, Inc., NDC labeler code 21922. 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 Vaginal Gel?
- 1 other product NDC are listed under this name. See all Metronidazole Vaginal Gel NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metronidazole Vaginal Gel products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metronidazole Vaginal Gelmetronidazole | Metronidazole 7.5 mg/g | GelVaginal | Aurobindo Pharma Limited | 59651-703 | 59651-0703-70 |