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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tacrolimus
- Listing expiration
- 2026-12-31
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 |
|---|
| 16729-422 | TACROLIMUS OINTMENT [ACCORD HEALTHCARE INC.] | 5 | Current NDC, Legacy NDC, 6 package rows | 20241006_80e6817a-9b1e-4f0f-e053-2a91aa0a3d15.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 |
|---|
| 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 |