clobetasol propionate
- Product NDC
- 43386-096
- 11-digit product format
- 433860096
- Labeler code
- 43386
- Product ID
- 43386-096_370129be-84f5-4edf-b821-ffbad2db8c66
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clobetasol propionate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Lupin Pharmaceuticals,Inc.
- Application
- ANDA208841
- Marketing category
- ANDA
- Marketing start
- 2018-06-02
- 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 table| Ingredient | Strength |
|---|
| CLOBETASOL PROPIONATE | .5 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 779619577M |
| Rxcui | 861448 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43386-096-60 | clobetasol propionate | 15 g in 1 TUBE | OINTMENT | 15 | | 1 |
| 43386-096-60 | clobetasol propionate | 1 in 1 CARTON | OINTMENT | 1 | | 1 |
| 43386-096-61 | clobetasol propionate | 1 in 1 CARTON | OINTMENT | 1 | | 1 |
| 43386-096-61 | clobetasol propionate | 30 g in 1 TUBE | OINTMENT | 30 | | 1 |
| 43386-096-62 | clobetasol propionate | 60 g in 1 TUBE | OINTMENT | 60 | | 1 |
| 43386-096-62 | clobetasol propionate | 1 in 1 CARTON | OINTMENT | 1 | | 1 |
| 43386-096-63 | clobetasol propionate | 45 g in 1 TUBE | OINTMENT | 45 | | 1 |
| 43386-096-63 | clobetasol propionate | 1 in 1 CARTON | OINTMENT | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43386-096 | CLOBETASOL PROPIONATE OINTMENT [LUPIN PHARMACEUTICALS,INC.] | 1 | Current NDC, Legacy NDC, 8 package rows | 20180814_3e0fe7b1-f511-491f-b74d-3ca00449835b.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 |
|---|
| 43386-096-60 | 43386009660 | 1 TUBE in 1 CARTON (43386-096-60) / 15 g in 1 TUBE | 1 tube | 2018-06-02 | 0000-00-00 | No | No | Current |
| 43386-096-61 | 43386009661 | 1 TUBE in 1 CARTON (43386-096-61) / 30 g in 1 TUBE | 1 tube | 2018-06-02 | 0000-00-00 | No | No | Current |
| 43386-096-62 | 43386009662 | 1 TUBE in 1 CARTON (43386-096-62) / 60 g in 1 TUBE | 1 tube | 2018-06-02 | 0000-00-00 | No | No | Current |
| 43386-096-63 | 43386009663 | 1 TUBE in 1 CARTON (43386-096-63) / 45 g in 1 TUBE | 1 tube | 2018-06-02 | 0000-00-00 | No | No | Current |