Prescription drug · ANDA
Halobetasol Propionate NDC 0713-0339
Halobetasol propionate .5 mg/g · Ointment · Topical · Cosette Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0713-0339-15 | 00713033915 | 1 TUBE in 1 CARTON (0713-0339-15) / 15 g in 1 TUBEMarketed from Feb 21, 2018 | |
| 0713-0339-86 | 00713033986 | 1 TUBE in 1 CARTON (0713-0339-86) / 50 g in 1 TUBEMarketed from Feb 21, 2018 |
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)
- Halobetasol Propionate
- Generic name (nonproprietary)
- halobetasol propionate
- Active ingredients
- Halobetasol propionate — .5 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Cosette Pharmaceuticals, Inc.NDC labeler code 0713
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077109
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0713-0339_163af771-5ae8-ac38-e063-6294a90ae5bdSPL ID 163af771-5ae8-ac38-e063-6294a90ae5bdSPL set ID f12ff257-dd77-4f9c-97c4-339784772d9fRxCUI 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
N400713033915followed by a unit qualifier and the quantityPackage 00713-0339-15. 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
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. Use in children 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.
About NDC 0713-0339
- What is NDC 0713-0339?
- 0713-0339 is the product NDC for Halobetasol Propionate, Halobetasol propionate .5 mg/g ointment, listed with the FDA by Cosette Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Halobetasol Propionate.
- What is the active ingredient?
- Halobetasol propionate.
- Who is the labeler?
- Cosette Pharmaceuticals, Inc., NDC labeler code 0713. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Halobetasol Propionate?
- 13 other product NDCs are listed under this name. See all Halobetasol Propionate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Halobetasol Propionate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | OintmentTopical | Encube Ethicals, Inc. | 21922-108 | 21922-0108-0421922-0108-14 |
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | LotionTopical | Coral Way Pharma, LLC | 85437-008 | 85437-0008-60 |
| Halobetasol propionate | Halobetasol propionate .5 mg/g | Aerosol, FoamTopical | Mayne Pharma | 68308-769 | 68308-0769-50 |
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | OintmentTopical | QUAGEN PHARMACEUTICALS LLC | 70752-119 | 70752-0119-0270752-0119-04 |
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 72162-2067 | 72162-2067-0272162-2067-04 |
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | OintmentTopical | Padagis Israel Pharmaceuticals Ltd | 45802-131 | 45802-0131-3245802-0131-35 |
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-8664 | 63629-8664-01 |
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 63629-8665 | 63629-8665-01 |
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | OintmentTopical | Bryant Ranch Prepack | 72162-1396 | 72162-1396-0272162-1396-04 |
| Halobetasol Propionate | Halobetasol propionate .5 mg/g | CreamTopical | Padagis Israel Pharmaceuticals Ltd | 45802-129 | 45802-0129-3245802-0129-35 |
Other NDCs under ANDA 077109
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 | 72162-2258 |