Prescription drug · ANDA
Halobetasol Propionate NDC 45802-131
Halobetasol propionate .5 mg/g · Ointment · Topical · Padagis Israel Pharmaceuticals Ltd
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45802-131-32 | 45802013132 | 1 TUBE in 1 CARTON (45802-131-32) / 50 g in 1 TUBEMarketed from Feb 5, 2009 | |
| 45802-131-35 | 45802013135 | 1 TUBE in 1 CARTON (45802-131-35) / 15 g in 1 TUBEMarketed from Jan 14, 2010 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Halobetasol Propionate
- Generic name (nonproprietary)
- halobetasol propionate
- Active ingredients
- Halobetasol propionate — .5 mg/g
- Dosage form
- Ointment
- Route
- Topical
- 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 45802-131_c43eed9c-3fb7-4933-ad26-9d65db4aa474SPL ID c43eed9c-3fb7-4933-ad26-9d65db4aa474SPL set ID c420da92-a3e3-4760-8cad-e50cbacebfebRxCUI 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
N445802013132followed by a unit qualifier and the quantityPackage 45802-0131-32. 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 indicated 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 | Bryant Ranch Prepack | 63629-8665 |
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-8664 |