Prescription drug · NDA
Noritate (Metronidazole) NDC 0187-5202
Metronidazole 10 mg/60g · Cream · Topical · Bausch Health US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0187-5202-60 | 00187520260 | 1 TUBE in 1 CARTON (0187-5202-60) / 60 g in 1 TUBEMarketed from Sep 8, 2013 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Noritate
- Generic name (nonproprietary)
- metronidazole
- Active ingredients
- Metronidazole — 10 mg/60g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bausch Health US, LLCNDC labeler code 0187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020743
- Marketing start
- Listing expires
- Other FDA classes
- Nitroimidazoles (Chemical structure)
- Identifiers
- Product ID 0187-5202_453f532e-bb72-4ea7-b9e5-b9ac903ffafeSPL ID 453f532e-bb72-4ea7-b9e5-b9ac903ffafeSPL set ID 706b09da-6cf9-421d-8e91-f3999474d322RxCUI 213120, 311680UNII 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 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
N400187520260followed by a unit qualifier and the quantityPackage 00187-5202-60. 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 Noritate is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.
Excerpt only. Read the full label for complete information.
About NDC 0187-5202
- What is NDC 0187-5202?
- 0187-5202 is the product NDC for Noritate (metronidazole), Metronidazole 10 mg/60g cream, listed with the FDA by Bausch Health US, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Noritate (Metronidazole).
- What is the active ingredient?
- Metronidazole.
- Who is the labeler?
- Bausch Health US, LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Noritate?
- 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.
Other NDCs under NDA 020743
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/60g | CreamTopical | Oceanside Pharmaceuticals | 68682-202 |