Prescription drug · ANDA
Halobetasol Propionate NDC 63629-8665
Halobetasol propionate .5 mg/g · Ointment · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-8665-1 | 63629866501 | 1 TUBE in 1 CARTON (63629-8665-1) / 50 g in 1 TUBEMarketed from Feb 5, 2009 |
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)
- Halobetasol Propionate
- Generic name (nonproprietary)
- halobetasol propionate
- Active ingredients
- Halobetasol 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 076872
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 63629-8665_1a273dc4-ba65-4b39-9ba1-d20f1259ae81SPL ID 1a273dc4-ba65-4b39-9ba1-d20f1259ae81SPL set ID 83725d7b-0788-4903-a75a-8e318ee7b568RxCUI 977978UNII 91A0K1TY3Z
- 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
N463629866501followed by a unit qualifier and the quantityPackage 63629-8665-01. 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 Halobetasol propionate ointment, 0.05% is a super-high potency corticosteroid indictated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond two 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076872
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 |
|---|---|---|---|---|
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 72162-1396 |
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | OintmentTopical | Padagis Israel Pharmaceuticals Ltd | 45802-131 |
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-8664 |