Halobetasol Propionate
- Product NDC
- 42254-250
- 11-digit product format
- 422540250
- Labeler code
- 42254
- Product ID
- 42254-250_4ff074d6-3aa3-47cd-9667-cace82ba5185
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Halobetasol Propionate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Rebel Distributors Corp
- Application
- ANDA078162
- Marketing category
- ANDA
- Marketing start
- 2007-07-16
- Marketing end
- 0000-00-00
- Substance
- HALOBETASOL PROPIONATE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a107c35c-2cb4-4734-a92b-e9ed5cfc34d6 | Product name | 2 | 20260220 |
| 9314f950-fe47-4276-b1f9-66d9d4a64eae | Product name | 1 | 20220217 |
| 0bc08e12-b8ed-4802-abab-926d5509afb3 | Product name | 1 | 20210513 |
| 608e9379-3a63-4bf4-b035-b393ae8faa97 | Product name | 1 | 20190214 |
| 83c1408d-b2bb-43b6-84ca-4f3e3e6f11d3 | Product name | 1 | 20151123 |
| 9badac54-f0c2-d87e-de70-c4ea0b9cf6a2 | Product name | 1 | 20140508 |
| ee2f33ab-1561-3107-e994-434cb17b4d06 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 42254-250-15 | 2019-09-24 | C162847 | 48780-1 | 9350213a-3c89-c013-e053-90daa90a1393 | Halobetasol Propionate Cream, 0.05% For Dermatological Use Only. Not for Ophthalmic Use. Rx Only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 42254-250-15 | Halobetasol Propionate | 15 g in 1 TUBE | CREAM | 15 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 42254-250-15 | GM - Gram | 42254-250 | 5848df13-acd8-4e06-93b1-ebdcedd000e7 | 1 | 2013-03-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| Halobetasol Propionate | ACTIVE INGREDIENT | 91A0K1TY3Z | HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| Halobetasol | ACTIVE MOIETY | 9P6159HM7T | HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| Cetyl Alcohol | INACTIVE INGREDIENT | 936JST6JCN | HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| DIAZOLIDINYL UREA | INACTIVE INGREDIENT | H5RIZ3MPW4 | HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| Isopropyl Palmitate | INACTIVE INGREDIENT | 8CRQ2TH63M | HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| Methylisothiazolinone | INACTIVE INGREDIENT | 229D0E1QFA | HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | HALOBETASOL PROPIONATE CREAM [REBEL DISTRIBUTORS CORP] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 977990 | halobetasol propionate 0.05 % Topical Cream | PSN | 4ff074d6-3aa3-47cd-9667-cace82ba5185 | 1 |
| 977990 | halobetasol propionate 0.5 MG/ML Topical Cream | SCD | 4ff074d6-3aa3-47cd-9667-cace82ba5185 | 1 |
| 977990 | halobetasol propionate 0.05 % Topical Cream | SY | 4ff074d6-3aa3-47cd-9667-cace82ba5185 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 42254-250-15 | 42254025015 | 15 g in 1 TUBE | 15 g | Historical |