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
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| df369ad4-19d8-393a-de46-8c6255b8b360 | Product name | 8 | 20251120 |
| d2a74186-7b26-dbcc-9435-50b3d0be14ab | Product name | 2 | 20250114 |
| a64835ae-fa9d-41d8-9a93-36828ba72b96 | Product name | 3 | 20190611 |
| b4a869e4-9fcd-47bd-95e3-85e7c75f8bad | Product name | 1 | 20150819 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68462-534-35 | Tacrolimus | 1 in 1 CARTON | OINTMENT | 1 | 8 | |
| 68462-534-35 | Tacrolimus | 30 g in 1 TUBE | OINTMENT | 30 | 8 | |
| 68462-534-65 | Tacrolimus | 1 in 1 CARTON | OINTMENT | 1 | 8 | |
| 68462-534-65 | Tacrolimus | 60 g in 1 TUBE | OINTMENT | 60 | 8 | |
| 68462-534-94 | Tacrolimus | 100 g in 1 TUBE | OINTMENT | 100 | 8 | |
| 68462-534-94 | Tacrolimus | 1 in 1 CARTON | OINTMENT | 1 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68462-534-35 | GM - Gram | 68462-534 | 00663add-945e-4894-a8f8-a24a3c535ad9 | 1 | 2018-06-11 |
| 68462-534-65 | GM - Gram | 68462-534 | 9b45d203-901c-49fe-a345-918cdd34749e | 1 | 2018-06-11 |
| 68462-534-94 | GM - Gram | 68462-534 | aab32b1b-5de5-42ae-af6b-eb702c63e2c0 | 1 | 2018-06-11 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313189 | tacrolimus 0.03 % Topical Ointment | PSN | c2d2e3a1-f346-4245-b445-6dd44e371180 | 8 |
| 314266 | tacrolimus 0.1 % Topical Ointment | PSN | c2d2e3a1-f346-4245-b445-6dd44e371180 | 8 |
| 313189 | tacrolimus 0.0003 MG/MG Topical Ointment | SCD | c2d2e3a1-f346-4245-b445-6dd44e371180 | 8 |
| 314266 | tacrolimus 0.001 MG/MG Topical Ointment | SCD | c2d2e3a1-f346-4245-b445-6dd44e371180 | 8 |
| 313189 | tacrolimus (as tacrolimus monohydrate) 0.0003 MG/MG Topical Ointment | SY | c2d2e3a1-f346-4245-b445-6dd44e371180 | 8 |
| 314266 | tacrolimus (as tacrolimus monohydrate) 0.001 MG/MG Topical Ointment | SY | c2d2e3a1-f346-4245-b445-6dd44e371180 | 8 |
| 313189 | tacrolimus 0.03 % Topical Ointment | SY | c2d2e3a1-f346-4245-b445-6dd44e371180 | 8 |
| 314266 | tacrolimus 0.1 % Topical Ointment | SY | c2d2e3a1-f346-4245-b445-6dd44e371180 | 8 |
Packages#
| 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 |