Prescription drug · ANDA
Clobetasol Propionate NDC 63629-2455
clobetasol propionate ointment usp, 0.05% · Clobetasol propionate .5 mg/g · Ointment · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2455-1 | 63629245501 | 1 TUBE in 1 CARTON (63629-2455-1) / 60 g in 1 TUBEMarketed from Nov 18, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Clobetasol Propionate
- Generic name (nonproprietary)
- clobetasol propionate ointment usp, 0.05%
- Active ingredients
- Clobetasol propionate — .5 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211295
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63629-2455_1c287e80-18d9-49ef-94c4-05b973402f45SPL ID 1c287e80-18d9-49ef-94c4-05b973402f45SPL set ID d6a0f4ca-dd42-4af3-85e5-8c61c0ba6ae2RxCUI 861448UNII 779619577M
- Pharmacologic class
- 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
N463629245501followed by a unit qualifier and the quantityPackage 63629-2455-01. 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 Clobetasol propionate ointment USP, 0.05% is super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary- adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211295
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 |
|---|---|---|---|---|
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 71335-2860 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 71335-2859 |
| Clobetasol Propionateclobetasol propionate usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | A-S Medication Solutions | 50090-6731 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-017 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-2456 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-2457 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-2458 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 72162-1273 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 71335-2837 |
| Clobetasol Propionateclobetasol propionate ointment, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Preferred Pharmaceuticals Inc. | 68788-7963 |
| Clobetasol Propionateclobetasol propionate ointment usp, 0.05% | Clobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 71335-2851 |