Prograf
- Product NDC
- 43353-178
- 11-digit product format
- 433530178
- Labeler code
- 43353
- Product ID
- 43353-178_b0d8a6ff-5163-4f29-abcd-8318b92bbef9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tacrolimus
- Dosage form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- NDA050708
- Marketing category
- NDA
- Marketing start
- 1994-04-08
- Marketing end
- 0000-00-00
- Substance
- TACROLIMUS
- Active strength
- 1 mg/1
- Pharmacologic classes
- Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 43353-178-09 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f7af-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF ® (tacrolimus) capsules, USP PROGRAF ® (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994 |
| 43353-178-53 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f7af-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF ® (tacrolimus) capsules, USP PROGRAF ® (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994 |
| 43353-178-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f7af-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF ® (tacrolimus) capsules, USP PROGRAF ® (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994 |
| 43353-178-80 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-f7af-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use PROGRAF safely and effectively. See full prescribing information for PROGRAF. PROGRAF ® (tacrolimus) capsules, USP PROGRAF ® (tacrolimus) injection, (for intravenous use) Initial U.S. Approval: 1994 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43353-178-09 | Prograf | 9000 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 9000 | | 1 |
| 43353-178-53 | Prograf | 60 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 60 | | 1 |
| 43353-178-60 | Prograf | 90 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 90 | | 1 |
| 43353-178-80 | Prograf | 180 in 1 BOTTLE, PLASTIC | CAPSULE, GELATIN COATED | 180 | | 1 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43353-178 | PROGRAF (TACROLIMUS) CAPSULE, GELATIN COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] | 1 | Legacy NDC, 4 package rows | 20140521_1e56c550-1c2b-4177-8e49-26303e9e335f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 43353-178-09 | 43353017809 | 9000 in 1 BOTTLE, PLASTIC | Historical |
| 43353-178-53 | 43353017853 | 60 in 1 BOTTLE, PLASTIC | Historical |
| 43353-178-60 | 43353017860 | 90 in 1 BOTTLE, PLASTIC | Historical |
| 43353-178-80 | 43353017880 | 180 in 1 BOTTLE, PLASTIC | Historical |