Prescription drug · ANDA
Metronidazole Vaginal Gel, 0.75% (Metronidazole) NDC 21922-039
Metronidazole 7.5 mg/g · Gel · Vaginal · Encube Ethicals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 21922-039-23 | 2192200392321922003923 | 1 TUBE, WITH APPLICATOR in 1 CARTON (21922-039-23) / 70 g in 1 TUBE, WITH APPLICATORMarketed from Jun 17, 2023 |
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, 0.75%
- Generic name (nonproprietary)
- metronidazole
- Active ingredients
- Metronidazole — 7.5 mg/g
- 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 215610
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 21922-039_15d347d5-e345-4750-9f5e-6c2b4f9c583aSPL ID 15d347d5-e345-4750-9f5e-6c2b4f9c583aSPL set ID 63ed1e7e-d264-4e35-af83-ec37fa5b06d1RxCUI 142046UNII 140QMO216EUPC 0321922039238
- 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
N421922003923followed by a unit qualifier and the quantityPackage 21922-0039-23. 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)
INDICATIONS AND USAGE Metronidazole vaginal gel is indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). NOTE For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b…
Excerpt only. Read the full label for complete information.
About NDC 21922-039
- What is NDC 21922-039?
- 21922-039 is the product NDC for Metronidazole Vaginal Gel, 0.75% (metronidazole), Metronidazole 7.5 mg/g 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, 0.75% (Metronidazole).
- 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, 0.75%?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.