Prescription drug · ANDA
Clotrimazole and Betamethasone Dipropionate NDC 0472-0379
Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g · Cream · Topical · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0472-0379-15 | 00472037915 | 1 TUBE in 1 CARTON (0472-0379-15) / 15 g in 1 TUBEMarketed from Dec 16, 2003 | |
| 0472-0379-45 | 00472037945 | 1 TUBE in 1 CARTON (0472-0379-45) / 45 g in 1 TUBEMarketed from Dec 16, 2003 |
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)
- Clotrimazole and Betamethasone Dipropionate
- Generic name (nonproprietary)
- clotrimazole and betamethasone dipropionate
- Active ingredients
- Clotrimazole — 10 mg/gBetamethasone dipropionate — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076002
- Marketing start
- Listing expires
- Other FDA classes
- Azoles (Chemical structure)Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0472-0379_6ecf0409-4072-415c-8381-658cce80bc76SPL ID 6ecf0409-4072-415c-8381-658cce80bc76SPL set ID a6ac4020-2c67-426a-8289-7e54ce43d0c9RxCUI 308714UNII G07GZ97H65, 826Y60901U
- Pharmacologic class
- Azole Antifungal; Corticosteroid
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
N400472037915followed by a unit qualifier and the quantityPackage 00472-0379-15. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 076002
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 |
|---|---|---|---|---|
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-0741 |
| Clotrimazole/Betameth | Betamethasone dipropionate .5 mg/g; Clotrimazole 10 mg/g | CreamTopical | Direct_Rx | 72189-518 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Proficient Rx LP | 63187-095 |
| Clotrimazole and Betamethasone Dipropionate | Clotrimazole 10 mg/g; Betamethasone dipropionate .5 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-8758 |