Safyral
- Product NDC
- 50419-403
- 11-digit product format
- 504190403
- Labeler code
- 50419
- Product ID
- 50419-403_e2c77609-66d5-4e76-8f2b-060c9e30b5e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium
- Dosage form
- KIT
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA022574
- Marketing category
- NDA
- Marketing start
- 2012-02-13
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Safyral
- Listing expiration
- 2027-12-31
Harmonized Identifiers#
| Field | Values |
|---|---|
| Rxcui | 1013628, 1050492, 1050493, 1050494 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50419-403-00 | Safyral | 1 in 1 BLISTER PACK | KIT | 1 | 23 | |
| 50419-403-00 | Safyral | 90 in 1 PACKAGE | KIT | 90 | 23 | |
| 50419-403-01 | Safyral | 1 in 1 BLISTER PACK | KIT | 1 | 23 | |
| 50419-403-03 | Safyral | 3 in 1 PACKAGE | KIT | 3 | 23 | |
| 50419-403-70 | Safyral | 90 in 1 PACKAGE | KIT | 90 | 23 | |
| 50419-403-70 | Safyral | 1 in 1 BLISTER PACK | KIT | 1 | 23 | |
| 50419-403-71 | Safyral | 1 in 1 BLISTER PACK | KIT | 1 | 23 | |
| 50419-403-75 | Safyral | 12 in 1 CARTON | KIT | 12 | 23 | |
| 50419-403-75 | Safyral | 5 in 1 PACKAGE | KIT | 5 | 23 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50419-403-01 | EA - Each | 50419-403 | f821ffec-4a56-42c7-9143-b16e58f977b4 | 1 | 2016-02-04 |
| 50419-403-03 | EA - Each | 50419-403 | 6c27e5cf-2277-47be-927b-cdc9597f83fc | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50419-403 | SAFYRAL (DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.] | 20 | Current NDC, Legacy NDC, 9 package rows | 20241122_97563516-306a-4e17-9690-edbda49ecd83.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1050494 | {21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet) / 7 (levomefolate calcium 0.451 MG Oral Tablet) } Pack [Safyral 28 Day] | BPCK | 97563516-306a-4e17-9690-edbda49ecd83 | 23 |
| 1050493 | {21 (drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet) / 7 (levomefolate calcium 0.451 MG Oral Tablet) } Pack | GPCK | 97563516-306a-4e17-9690-edbda49ecd83 | 23 |
| 1050493 | Drospiren-Eth estra-Levomefol Ca 3-0.03-0.451 MG (21) Oral Tablet / Levomefol Ca 0.451 MG (7) Oral Tablet 28 Day Pack | PSN | 97563516-306a-4e17-9690-edbda49ecd83 | 23 |
| 1050492 | drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet | PSN | 97563516-306a-4e17-9690-edbda49ecd83 | 23 |
| 1013628 | levomefolate calcium 0.451 MG Oral Tablet | PSN | 97563516-306a-4e17-9690-edbda49ecd83 | 23 |
| 1050494 | SAFYRAL 28 Day Pack | PSN | 97563516-306a-4e17-9690-edbda49ecd83 | 23 |
| 1050492 | drospirenone 3 MG / ethinyl estradiol 0.03 MG / levomefolate calcium 0.451 MG Oral Tablet | SCD | 97563516-306a-4e17-9690-edbda49ecd83 | 23 |
| 1013628 | levomefolate calcium 0.451 MG Oral Tablet | SCD | 97563516-306a-4e17-9690-edbda49ecd83 | 23 |
| 1050494 | Safyral 28 Day Pack | SY | 97563516-306a-4e17-9690-edbda49ecd83 | 23 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50419-403-00 | 50419040300 | 90 BLISTER PACK in 1 PACKAGE (50419-403-00) / 1 KIT in 1 BLISTER PACK | 90 blister pack | 2012-02-13 | 0000-00-00 | No | No | Current |
| 50419-403-01 | 50419040301 | 1 in 1 BLISTER PACK | Historical | |||||
| 50419-403-03 | 50419040303 | 3 BLISTER PACK in 1 PACKAGE (50419-403-03) / 1 KIT in 1 BLISTER PACK (50419-403-01) | 3 blister pack | 2012-02-13 | 0000-00-00 | No | No | Current |
| 50419-403-70 | 50419040370 | 90 BLISTER PACK in 1 PACKAGE (50419-403-70) / 1 KIT in 1 BLISTER PACK | 90 blister pack | 2012-02-13 | 0000-00-00 | No | No | Current |
| 50419-403-71 | 50419040371 | 1 in 1 BLISTER PACK | Historical | |||||
| 50419-403-75 | 50419040375 | 12 PACKAGE in 1 CARTON (50419-403-75) / 5 BLISTER PACK in 1 PACKAGE / 1 KIT in 1 BLISTER PACK (50419-403-71) | 12 package | 2012-02-13 | 0000-00-00 | No | No | Current |