Pimecrolimus
- Product NDC
- 68462-609
- 11-digit product format
- 684620609
- Labeler code
- 68462
- Product ID
- 68462-609_693578a9-44f8-442b-b186-ccb367cc7cf0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pimecrolimus
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA211769
- Marketing category
- ANDA
- Marketing start
- 2019-08-29
- 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#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-609 | PIMECROLIMUS CREAM [GLENMARK PHARMACEUTICALS INC., USA] | 2 | Current NDC, Legacy NDC, 6 package rows | 20240104_ac52a235-1b6f-47a2-b3d9-8d538eeae02f.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 |
|---|
| 68462-609-35 | 68462060935 | 1 TUBE in 1 CARTON (68462-609-35) / 30 g in 1 TUBE | 1 tube | 2019-08-29 | 0000-00-00 | No | No | Current |
| 68462-609-65 | 68462060965 | 1 TUBE in 1 CARTON (68462-609-65) / 60 g in 1 TUBE | 1 tube | 2019-08-29 | 0000-00-00 | No | No | Current |
| 68462-609-94 | 68462060994 | 1 TUBE in 1 CARTON (68462-609-94) / 100 g in 1 TUBE | 1 tube | 2019-08-29 | 0000-00-00 | No | No | Current |