Tacrolimus
- Product NDC
- 68462-534
- 11-digit product format
- 684620534
- Labeler code
- 68462
- Product ID
- 68462-534_15dcd504-ee3e-4f0f-a765-55e31511641e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Glenmark Pharmaceuticals Inc., USA
- Application
- ANDA210393
- Marketing category
- ANDA
- Marketing start
- 2018-04-16
- Substance
- TACROLIMUS
- Active strength
- 1 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
- Tacrolimus
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TACROLIMUS | 1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | WM0HAQ4WNM |
| Rxcui | 313189, 314266 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68462-534 | TACROLIMUS OINTMENT [GLENMARK PHARMACEUTICALS INC., USA] | 7 | Current NDC, Legacy NDC, 6 package rows | 20230822_c2d2e3a1-f346-4245-b445-6dd44e371180.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 |
|---|
| 68462-534-35 | 68462053435 | 1 TUBE in 1 CARTON (68462-534-35) / 30 g in 1 TUBE | 1 tube | 2018-04-16 | 0000-00-00 | No | No | Current |
| 68462-534-65 | 68462053465 | 1 TUBE in 1 CARTON (68462-534-65) / 60 g in 1 TUBE | 1 tube | 2018-04-16 | 0000-00-00 | No | No | Current |
| 68462-534-94 | 68462053494 | 1 TUBE in 1 CARTON (68462-534-94) / 100 g in 1 TUBE | 1 tube | 2018-04-16 | 0000-00-00 | No | No | Current |