Tacrolimus
- Product NDC
- 16729-422
- 11-digit product format
- 167290422
- Labeler code
- 16729
- Product ID
- 16729-422_23a804e6-2854-6b9b-e063-6394a90af669
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA211688
- Marketing category
- ANDA
- Marketing start
- 2019-05-31
- Substance
- TACROLIMUS
- Active strength
- 1 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
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 |
|---|---|---|---|---|---|---|
| 16729-422-01 | Tacrolimus | 1 in 1 CARTON | OINTMENT | 1 | 5 | |
| 16729-422-01 | Tacrolimus | 100 g in 1 TUBE | OINTMENT | 100 | 5 | |
| 16729-422-10 | Tacrolimus | 1 in 1 CARTON | OINTMENT | 1 | 5 | |
| 16729-422-10 | Tacrolimus | 30 g in 1 TUBE | OINTMENT | 30 | 5 | |
| 16729-422-12 | Tacrolimus | 1 in 1 CARTON | OINTMENT | 1 | 5 | |
| 16729-422-12 | Tacrolimus | 60 g in 1 TUBE | OINTMENT | 60 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 16729-422-01 | GM - Gram | 16729-422 | 0e60d9f1-40ea-4dd6-8449-8d75621879f7 | 1 | 2019-06-19 |
| 16729-422-10 | GM - Gram | 16729-422 | dbe45e7a-2b4a-4dc0-8285-3ad7f576e088 | 1 | 2019-06-19 |
| 16729-422-12 | GM - Gram | 16729-422 | 02d25f3f-c439-405a-8a75-1f6c11ba7a35 | 1 | 2019-06-19 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313189 | tacrolimus 0.03 % Topical Ointment | PSN | 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15 | 5 |
| 314266 | tacrolimus 0.1 % Topical Ointment | PSN | 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15 | 5 |
| 313189 | tacrolimus 0.0003 MG/MG Topical Ointment | SCD | 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15 | 5 |
| 314266 | tacrolimus 0.001 MG/MG Topical Ointment | SCD | 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15 | 5 |
| 313189 | tacrolimus (as tacrolimus monohydrate) 0.0003 MG/MG Topical Ointment | SY | 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15 | 5 |
| 314266 | tacrolimus (as tacrolimus monohydrate) 0.001 MG/MG Topical Ointment | SY | 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15 | 5 |
| 313189 | tacrolimus 0.03 % Topical Ointment | SY | 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15 | 5 |
| 314266 | tacrolimus 0.1 % Topical Ointment | SY | 80e6817a-9b1e-4f0f-e053-2a91aa0a3d15 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16729-422-01 | 16729042201 | 1 TUBE in 1 CARTON (16729-422-01) / 100 g in 1 TUBE | 1 tube | 2019-06-05 | 0000-00-00 | No | No | Current |
| 16729-422-10 | 16729042210 | 1 TUBE in 1 CARTON (16729-422-10) / 30 g in 1 TUBE | 1 tube | 2019-05-31 | 0000-00-00 | No | No | Current |
| 16729-422-12 | 16729042212 | 1 TUBE in 1 CARTON (16729-422-12) / 60 g in 1 TUBE | 1 tube | 2019-05-31 | 0000-00-00 | No | No | Current |