Halobetasol Propionate
- Product NDC
- 45802-131
- 11-digit product format
- 458020131
- Labeler code
- 45802
- Product ID
- 45802-131_c43eed9c-3fb7-4933-ad26-9d65db4aa474
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Halobetasol Propionate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA076872
- Marketing category
- ANDA
- Marketing start
- 2009-02-05
- Substance
- HALOBETASOL PROPIONATE
- Active strength
- .5 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Halobetasol Propionate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HALOBETASOL PROPIONATE | .5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 91A0K1TY3Z |
| Rxcui | 977978 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 45802-131-32 | Halobetasol Propionate | 1 in 1 CARTON | OINTMENT | 1 | | 6 |
| 45802-131-32 | Halobetasol Propionate | 50 g in 1 TUBE | OINTMENT | 50 | | 6 |
| 45802-131-35 | Halobetasol Propionate | 15 g in 1 TUBE | OINTMENT | 15 | | 6 |
| 45802-131-35 | Halobetasol Propionate | 1 in 1 CARTON | OINTMENT | 1 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Halobetasol Propionate | ACTIVE INGREDIENT | 91A0K1TY3Z | HALOBETASOL PROPIONATE OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| Halobetasol Propionate | ACTIVE INGREDIENT | 91A0K1TY3Z | HALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.] | 2 | |
| Halobetasol | ACTIVE MOIETY | 9P6159HM7T | HALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.] | 2 | |
| Halobetasol | ACTIVE MOIETY | 9P6159HM7T | HALOBETASOL PROPIONATE OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| ALUMINUM STEARATE | INACTIVE INGREDIENT | U6XF9NP8HM | HALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.] | 2 | |
| ALUMINUM STEARATE | INACTIVE INGREDIENT | U6XF9NP8HM | HALOBETASOL PROPIONATE OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | HALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.] | 2 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | HALOBETASOL PROPIONATE OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HALOBETASOL PROPIONATE OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.] | 2 | |
| SORBITAN SESQUIOLEATE | INACTIVE INGREDIENT | 0W8RRI5W5A | HALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.] | 2 | |
| SORBITAN SESQUIOLEATE | INACTIVE INGREDIENT | 0W8RRI5W5A | HALOBETASOL PROPIONATE OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | HALOBETASOL PROPIONATE OINTMENT [H.J. HARKINS COMPANY, INC.] | 2 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | HALOBETASOL PROPIONATE OINTMENT [PERRIGO NEW YORK INC] | 2 | |
| HALOBETASOL PROPIONATE | ACTIVE INGREDIENT | 91A0K1TY3Z | HALOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HALOBETASOL | ACTIVE MOIETY | 9P6159HM7T | HALOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| ALUMINUM STEARATE | INACTIVE INGREDIENT | U6XF9NP8HM | HALOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | HALOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | HALOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SORBITAN SESQUIOLEATE | INACTIVE INGREDIENT | 0W8RRI5W5A | HALOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| YELLOW WAX | INACTIVE INGREDIENT | 2ZA36H0S2V | HALOBETASOL PROPIONATE OINTMENT [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45802-131 | HALOBETASOL PROPIONATE OINTMENT [PADAGIS ISRAEL PHARMACEUTICALS LTD] | 6 | Current NDC, Legacy NDC, 4 package rows | 20240209_c420da92-a3e3-4760-8cad-e50cbacebfeb.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 45802-131-32 | 45802013132 | 1 TUBE in 1 CARTON (45802-131-32) / 50 g in 1 TUBE | 1 tube | 2009-02-05 | 0000-00-00 | No | No | Current |
| 45802-131-35 | 45802013135 | 1 TUBE in 1 CARTON (45802-131-35) / 15 g in 1 TUBE | 1 tube | 2010-01-14 | 0000-00-00 | No | No | Current |