Pimecrolimus
- Product NDC
- 68682-112
- 11-digit product format
- 686820112
- Labeler code
- 68682
- Product ID
- 68682-112_e391204d-95f9-4c57-a0db-578bdd1b8bde
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pimecrolimus
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Oceanside Pharmaceuticals
- Application
- NDA021302
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-11-26
- Substance
- PIMECROLIMUS
- Active strength
- 10 mg/g
- Pharmacologic classes
- Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pimecrolimus
- Listing expiration
- 2027-12-31
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 |
|---|
| 68682-112-03 | Pimecrolimus | 100 g in 1 TUBE | CREAM | 100 | | 4 |
| 68682-112-03 | Pimecrolimus | 1 in 1 CARTON | CREAM | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68682-112 | PIMECROLIMUS CREAM [OCEANSIDE PHARMACEUTICALS] | 3 | Current NDC, Legacy NDC, 2 package rows | 20201215_6601e43e-ce7d-446a-8568-8e7b24b86f06.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 |
|---|
| 68682-112-03 | 68682011203 | 1 TUBE in 1 CARTON (68682-112-03) / 100 g in 1 TUBE | 1 tube | 2018-11-26 | 0000-00-00 | No | No | Current |