Clobetasol Propionate
- Product NDC
- 0168-0163
- 11-digit product format
- 001680163
- Labeler code
- 0168
- Product ID
- 0168-0163_42f6771f-30f7-467e-94da-2334ea31fdab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clobetasol propionate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
- Application
- ANDA074392
- Marketing category
- ANDA
- Marketing start
- 1996-09-30
- Substance
- CLOBETASOL 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
- Clobetasol Propionate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLOBETASOL PROPIONATE | .5 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 779619577M |
| Rxcui | 861434, 861448, 861495 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0168-0163-15 | Clobetasol Propionate | 15 g in 1 TUBE | CREAM | 15 | 13 | |
| 0168-0163-30 | Clobetasol Propionate | 30 g in 1 TUBE | CREAM | 30 | 13 | |
| 0168-0163-46 | Clobetasol Propionate | 45 g in 1 TUBE | CREAM | 45 | 13 | |
| 0168-0163-60 | Clobetasol Propionate | 60 g in 1 TUBE | CREAM | 60 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0168-0163-15 | GM - Gram | 0168-0163 | 42e93e47-f8cd-4cc0-a812-a7d2b2994bfc | 1 | 2012-07-24 |
| 0168-0163-30 | GM - Gram | 0168-0163 | 890feac8-c5cd-4ccc-a91d-95542fb198dc | 1 | 2012-07-24 |
| 0168-0163-46 | GM - Gram | 0168-0163 | ed35ee8c-57c9-4227-870b-f1813e8d92aa | 1 | 2012-07-24 |
| 0168-0163-60 | GM - Gram | 0168-0163 | b3bf994d-b6bb-43dc-9e21-97105214d676 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0168-0163 | CLOBETASOL PROPIONATE OINTMENT CLOBETASOL PROPIONATE CREAM CLOBETASOL PROPIONATE GEL [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.] | 12 | Current NDC, Legacy NDC, 4 package rows | 20200919_2d4fa3a3-dc1c-4d3c-9959-4751e09d25be.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861495 | clobetasol propionate 0.05 % Topical Cream | PSN | 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be | 13 |
| 861434 | clobetasol propionate 0.05 % Topical Gel | PSN | 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be | 13 |
| 861448 | clobetasol propionate 0.05 % Topical Ointment | PSN | 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be | 13 |
| 861434 | clobetasol propionate 0.0005 MG/MG Topical Gel | SCD | 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be | 13 |
| 861448 | clobetasol propionate 0.0005 MG/MG Topical Ointment | SCD | 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be | 13 |
| 861495 | clobetasol propionate 0.5 MG/ML Topical Cream | SCD | 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be | 13 |
| 861495 | clobetasol propionate 0.05 % Topical Cream | SY | 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be | 13 |
| 861434 | clobetasol propionate 0.05 % Topical Gel | SY | 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be | 13 |
| 861448 | clobetasol propionate 0.05 % Topical Ointment | SY | 2d4fa3a3-dc1c-4d3c-9959-4751e09d25be | 13 |
| 861495 | clobetasol propionate 0.05 % Topical Cream | PSN | c5f0a0f3-5852-49d4-ae34-7ae8feaf1a6e | 4 |
| 861495 | clobetasol propionate 0.5 MG/ML Topical Cream | SCD | c5f0a0f3-5852-49d4-ae34-7ae8feaf1a6e | 4 |
| 861495 | clobetasol propionate 0.05 % Topical Cream | SY | c5f0a0f3-5852-49d4-ae34-7ae8feaf1a6e | 4 |
| 861495 | clobetasol propionate 0.05 % Topical Cream | PSN | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
| 861495 | clobetasol propionate 0.05 % Topical Cream | PSN | e0f7bc85-9c13-44df-9b37-c216ecfe3ffe | 1 |
| 861448 | clobetasol propionate 0.05 % Topical Ointment | PSN | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
| 861448 | clobetasol propionate 0.0005 MG/MG Topical Ointment | SCD | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
| 861495 | clobetasol propionate 0.5 MG/ML Topical Cream | SCD | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
| 861495 | clobetasol propionate 0.5 MG/ML Topical Cream | SCD | e0f7bc85-9c13-44df-9b37-c216ecfe3ffe | 1 |
| 861495 | clobetasol propionate 0.05 % Topical Cream | SY | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
| 861495 | clobetasol propionate 0.05 % Topical Cream | SY | e0f7bc85-9c13-44df-9b37-c216ecfe3ffe | 1 |
| 861448 | clobetasol propionate 0.05 % Topical Ointment | SY | df79a35c-ce5c-452e-b81e-50a014fc94f4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0168-0163-15 | 00168016315 | 15 g in 1 TUBE (0168-0163-15) | 15 g | 1996-09-30 | 0000-00-00 | No | No | Current |
| 0168-0163-30 | 00168016330 | 30 g in 1 TUBE (0168-0163-30) | 30 g | 1996-09-30 | 0000-00-00 | No | No | Current |
| 0168-0163-46 | 00168016346 | 45 g in 1 TUBE (0168-0163-46) | 45 g | 1996-09-30 | 0000-00-00 | No | No | Current |
| 0168-0163-60 | 00168016360 | 60 g in 1 TUBE (0168-0163-60) | 60 g | 1996-09-30 | 0000-00-00 | No | No | Current |