Prescription drug · ANDA
Clobetasol Propionate NDC 63629-2330
Clobetasol propionate .5 mg/g · Cream · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2330-1 | 63629233001 | 1 TUBE in 1 CARTON (63629-2330-1) / 45 g in 1 TUBEMarketed from Apr 19, 2021 |
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
- Active ingredients
- Clobetasol propionate — .5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210034
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63629-2330_79a244fb-f178-4a26-88ca-b45301d4c624SPL ID 79a244fb-f178-4a26-88ca-b45301d4c624SPL set ID 6d14d269-bae6-493a-81ed-83f6a3aa0f4fRxCUI 861495UNII 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
N463629233001followed by a unit qualifier and the quantityPackage 63629-2330-01. 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 cream is a super-high potency corticosteroid formulation 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 per 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 210034
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 Propionate | Clobetasol propionate .5 mg/g | CreamTopical | Xiromed, LLC | 70700-109 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-2332 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-2329 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | Bryant Ranch Prepack | 63629-2331 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | Bryant Ranch Prepack | 72162-1961 |
| Clobetasol Propionate | Clobetasol propionate .5 mg/g | CreamTopical | A-S Medication Solutions | 50090-5079 |