Prescription drug · ANDA
metronidazole vaginal (Metronidazole) NDC 45802-139
Metronidazole 7.5 mg/g · Gel · Vaginal · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-139-70 | 4580201397045802013970 | 1 TUBE in 1 CARTON (45802-139-70) / 70 g in 1 TUBEMarketed from Jul 8, 2019 |
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
- Generic name (nonproprietary)
- metronidazole
- Active ingredients
- Metronidazole — 7.5 mg/g
- Dosage form
- Gel
- Route
- Vaginal
- Labeler
- Padagis Israel Pharmaceuticals LtdNDC labeler code 45802
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211786
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 45802-139_ac51fedf-e650-40c6-a92f-d33d6f32e54bSPL ID ac51fedf-e650-40c6-a92f-d33d6f32e54bSPL set ID eb240e7b-cec8-497b-8a49-7ed768e2b431RxCUI 142046UNII 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
N445802013970followed by a unit qualifier and the quantityPackage 45802-0139-70. 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, (…
Excerpt only. Read the full label for complete information.
About NDC 45802-139
- What is NDC 45802-139?
- 45802-139 is the product NDC for metronidazole vaginal (metronidazole), Metronidazole 7.5 mg/g gel, listed with the FDA by Padagis Israel Pharmaceuticals Ltd. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- metronidazole vaginal (Metronidazole).
- What is the active ingredient?
- Metronidazole.
- Who is the labeler?
- Padagis Israel Pharmaceuticals Ltd, NDC labeler code 45802. 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?
- 4 other product NDCs are listed under this name. See all metronidazole vaginal 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 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 vaginalmetronidazole | Metronidazole 7.5 mg/g | GelVaginal | REMEDYREPACK INC. | 70518-4572 | 70518-4572-00 |
| metronidazole vaginalmetronidazole | Metronidazole 7.5 mg/g | GelVaginal | Saptalis Pharmaceuticals LLC | 71656-067 | 71656-0067-70 |
| metronidazole vaginalmetronidazole | Metronidazole 7.5 mg/g | GelVaginal | REMEDYREPACK INC. | 70518-2814 | 70518-2814-00 |
| metronidazole vaginalmetronidazole | Metronidazole 7.5 mg/g | GelVaginal | A-S Medication Solutions | 50090-4809 | 50090-4809-00 |
Other NDCs under ANDA 211786
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 vaginalmetronidazole | Metronidazole 7.5 mg/g | GelVaginal | A-S Medication Solutions | 50090-4809 |
| metronidazole vaginalmetronidazole | Metronidazole 7.5 mg/g | GelVaginal | REMEDYREPACK INC. | 70518-2814 |