Clobetasol Propionate
- Product NDC
- 50383-269
- 11-digit product format
- 503830269
- Labeler code
- 50383
- Product ID
- 50383-269_ab3ec2c7-dc10-4b1d-ab37-ff5ebfbe9b16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clobetasol Propionate
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Akorn
- Application
- ANDA076141
- Marketing category
- ANDA
- Marketing start
- 2010-06-07
- Marketing end
- 0000-00-00
- Substance
- CLOBETASOL PROPIONATE
- Active strength
- 1 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 20abe2c3-3e80-d2b2-39eb-3156e4af4799 | Product name | 3 | 20250124 |
| 45ad92f8-d116-4c0c-851c-2e740b7d8e6f | Product name | 1 | 20250122 |
| 42be0ad5-6fd7-4f1b-8108-6d9dd7d571df | Product name | 7 | 20250107 |
| 3813b789-94b9-edd6-f010-6b926dd462e5 | Product name | 5 | 20230113 |
| 30eee8a1-850e-41ed-b5ab-761301aeab49 | Product name | 6 | 20221206 |
| 18e5b6f7-c414-b1f1-b684-17fdd02c215e | Product name | 4 | 20210927 |
| 1c87bbde-dd91-a122-db33-67ae814cb645 | Product name | 7 | 20210510 |
| 519b5875-7d7d-4aa6-9d3d-470fa1376595 | Product name | 4 | 20200227 |
| 98669154-3e9c-47da-8a2c-656ab71848be | Product name | 2 | 20180607 |
| 8d4f8539-436f-453b-8b76-5322d403fc8e | Product name | 1 | 20180131 |
| 837ac3c6-ee71-c5a6-6eba-c4065f37e9f5 | Product name | 2 | 20171010 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50383-269-15 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5fe2-111a-e063-dadaa90a10e2 | Clobetasol Propionate Gel, 0.05% |
| 50383-269-30 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5fe2-111a-e063-dadaa90a10e2 | Clobetasol Propionate Gel, 0.05% |
| 50383-269-60 | 2024-01-30 | C162847 | 48780-1 | 1030e365-5fe2-111a-e063-dadaa90a10e2 | Clobetasol Propionate Gel, 0.05% |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50383-269-15 | GM - Gram | 50383-269 | c0a5d166-b858-4841-bdc3-f280a007ab39 | 1 | 2012-07-24 |
| 50383-269-30 | GM - Gram | 50383-269 | 5d3eb952-e097-462e-ba47-8520e4c3b19f | 1 | 2012-07-24 |
| 50383-269-60 | GM - Gram | 50383-269 | a0abd89f-120e-495c-9e6c-37cb42e5af2a | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| CLOBETASOL PROPIONATE | ACTIVE INGREDIENT | 779619577M | CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.] | 2 | |
| CLOBETASOL | ACTIVE MOIETY | ADN79D536H | CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.] | 2 | |
| CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | INACTIVE INGREDIENT | HHT01ZNK31 | CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.] | 2 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | CLOBETASOL PROPIONATE GEL [HI-TECH PHARMACAL CO., INC.] | 2 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50383-269-15 | 50383026915 | 1 TUBE in 1 CARTON (50383-269-15) > 15 g in 1 TUBE | 1 tube | 2010-06-07 | 0000-00-00 | No | No | Current |
| 50383-269-30 | 50383026930 | 1 TUBE in 1 CARTON (50383-269-30) > 30 g in 1 TUBE | 1 tube | 2010-06-07 | 0000-00-00 | No | No | Current |
| 50383-269-60 | 50383026960 | 1 TUBE in 1 CARTON (50383-269-60) > 60 g in 1 TUBE | 1 tube | 2010-06-07 | 0000-00-00 | No | No | Current |