pimecrolimus
- Product NDC
- 0591-2944
- 11-digit product format
- 005912944
- Labeler code
- 0591
- Product ID
- 0591-2944_a3f0bc92-796c-4f74-8c7a-63001b4e9e43
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- pimecrolimus
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA209345
- Marketing category
- ANDA
- Marketing start
- 2018-12-27
- Substance
- PIMECROLIMUS
- Active strength
- 10 mg/g
- Pharmacologic classes
- Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- pimecrolimus
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PIMECROLIMUS | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7KYV510875 |
| Rxcui | 562806 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0591-2944-30 | pimecrolimus | 30 g in 1 TUBE | CREAM | 30 | | 5 |
| 0591-2944-60 | pimecrolimus | 60 g in 1 TUBE | CREAM | 60 | | 5 |
| 0591-2944-87 | pimecrolimus | 100 g in 1 TUBE | CREAM | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-2944 | PIMECROLIMUS CREAM [ACTAVIS PHARMA, INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20181229_d5b0403a-065f-42e3-96d6-7dcb9ab127d3.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 |
|---|
| 0591-2944-30 | 00591294430 | 30 g in 1 TUBE (0591-2944-30) | 30 g | 2018-12-27 | 0000-00-00 | No | No | Current |
| 0591-2944-60 | 00591294460 | 60 g in 1 TUBE (0591-2944-60) | 60 g | 2018-12-27 | 0000-00-00 | No | No | Current |
| 0591-2944-87 | 00591294487 | 100 g in 1 TUBE (0591-2944-87) | 100 g | 2018-12-27 | 0000-00-00 | No | No | Current |