Clobetasol Propionate
- Product NDC
- 13668-569
- 11-digit product format
- 136680569
- Labeler code
- 13668
- Product ID
- 13668-569_e105f3a8-2dee-4547-9760-35e7a1da464a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clobetasol Propionate
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Torrent Pharmaceuticals Limited
- Application
- ANDA211836
- Marketing category
- ANDA
- Marketing start
- 2024-12-15
- Substance
- CLOBETASOL PROPIONATE
- Active strength
- .5 mg/g
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clobetasol Propionate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CLOBETASOL PROPIONATE | .5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 779619577M |
| Rxcui | 861495 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13668-569-01 | Clobetasol Propionate | 15 g in 1 TUBE | CREAM | 15 | | 10 |
| 13668-569-02 | Clobetasol Propionate | 30 g in 1 TUBE | CREAM | 30 | | 10 |
| 13668-569-04 | Clobetasol Propionate | 45 g in 1 TUBE | CREAM | 45 | | 10 |
| 13668-569-05 | Clobetasol Propionate | 60 g in 1 TUBE | CREAM | 60 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13668-569 | CLOBETASOL PROPIONATE CREAM [TORRENT PHARMACEUTICALS LIMITED] | 9 | Current NDC, Legacy NDC, 4 package rows | 20241215_6f930298-e410-4bfb-8c3f-456a1f55f4a9.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 |
|---|
| 13668-569-01 | 13668056901 | 15 g in 1 TUBE (13668-569-01) | 15 g | 2024-12-15 | 0000-00-00 | No | No | Current |
| 13668-569-02 | 13668056902 | 30 g in 1 TUBE (13668-569-02) | 30 g | 2024-12-15 | 0000-00-00 | No | No | Current |
| 13668-569-04 | 13668056904 | 45 g in 1 TUBE (13668-569-04) | 45 g | 2024-12-15 | 0000-00-00 | No | No | Current |
| 13668-569-05 | 13668056905 | 60 g in 1 TUBE (13668-569-05) | 60 g | 2024-12-15 | 0000-00-00 | No | No | Current |