Crotan
- Product NDC
- 0682-0051
- 11-digit product format
- 006820051
- Labeler code
- 0682
- Product ID
- 0682-0051_16625ecb-11aa-a097-e063-6294a90af3d5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Crotamiton
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Marnel Pharmaceuticals, Inc.
- Application
- ANDA087204
- Marketing category
- ANDA
- Marketing start
- 2022-01-15
- Substance
- CROTAMITON
- Active strength
- 100 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Crotan
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CROTAMITON | 100 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | D6S4O4XD0H |
| Rxcui | 106219, 2049603 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0682-0051-10 | Crotan | 237 g in 1 BOTTLE, PLASTIC | LOTION | 237 | | 11 |
| 0682-0051-20 | Crotan | 60 g in 1 BOTTLE, PLASTIC | LOTION | 60 | | 11 |
| 0682-0051-30 | Crotan | 454 g in 1 BOTTLE, PLASTIC | LOTION | 454 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0682-0051 | CROTAN (CROTAMITON) LOTION [MARNEL PHARMACEUTICALS, INC.] | 11 | Current NDC, Legacy NDC, 3 package rows | 20240420_6f7478fa-ed2b-4943-9d40-1fd0161a0854.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 |
|---|
| 0682-0051-10 | 00682005110 | 237 g in 1 BOTTLE, PLASTIC (0682-0051-10) | 237 g | 2022-01-15 | 0000-00-00 | No | No | Current |
| 0682-0051-20 | 00682005120 | 60 g in 1 BOTTLE, PLASTIC (0682-0051-20) | 60 g | 2022-01-15 | 0000-00-00 | No | No | Current |
| 0682-0051-30 | 00682005130 | 454 g in 1 BOTTLE, PLASTIC (0682-0051-30) | 454 g | 2022-01-15 | 0000-00-00 | No | No | Current |