SLYND
- Product NDC
- 0642-7470
- 11-digit product format
- 006427470
- Labeler code
- 0642
- Product ID
- 0642-7470_38dee500-6c7f-61ab-e063-6394a90a0bf8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Drospirenone
- Dosage form
- KIT
- Labeler
- Exeltis USA, Inc.
- Application
- NDA211367
- Marketing category
- NDA
- Marketing start
- 2019-06-06
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SLYND
- Listing expiration
- 2026-12-31
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Rxcui | 748797, 2171000, 2171001, 2171002 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 0642-7470-01 | 2024-08-07 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
| 0642-7470-02 | 2024-08-07 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
| 0642-7470-01 | 2024-07-30 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
| 0642-7470-02 | 2024-07-30 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
| 0642-7470-01 | 2024-01-30 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
| 0642-7470-02 | 2024-01-30 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
| 0642-7470-02 | 2022-11-17 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
| 0642-7470-03 | 2022-11-17 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
| 0642-7470-06 | 2022-11-17 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
| 0642-7470-02 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
| 0642-7470-03 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
| 0642-7470-06 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-9f89-d8a0-e053-dadaa90a6e4e | These highlights do not include all the information needed to use SLYND safely and effectively. See full prescribing information for SLYND. SLYND ® (drospirenone) tablets, for oral use Initial U.S. Approval: 2001 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0642-7470-01 | SLYND | 1 in 1 CARTON | KIT | 1 | | 8 |
| 0642-7470-02 | SLYND | 1 in 1 CARTON | KIT | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0642-7470 | SLYND (DROSPIRENONE) KIT [EXELTIS USA, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240809_db32bc55-f295-4d87-9dbb-0a2f45573dcf.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 |
|---|
| 0642-7470-01 | 00642747001 | 1 KIT in 1 CARTON (0642-7470-01) * 24 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2019-09-01 | 0000-00-00 | No | No | Current |
| 0642-7470-02 | 00642747002 | 1 KIT in 1 CARTON (0642-7470-02) * 24 TABLET, FILM COATED in 1 BLISTER PACK * 4 TABLET, FILM COATED in 1 BLISTER PACK | 1 kit | 2019-09-01 | 0000-00-00 | Yes | No | Current |
| 0642-7470-03 | 00642747003 | 3 BLISTER PACK in 1 CARTON (0642-7470-03) > 28 TABLET, FILM COATED in 1 BLISTER PACK (0642-7470-01) | 3 blister pack | 2019-09-01 | 0000-00-00 | No | No | Current |
| 0642-7470-06 | 00642747006 | 6 BLISTER PACK in 1 CARTON (0642-7470-06) > 28 TABLET, FILM COATED in 1 BLISTER PACK (0642-7470-01) | 6 blister pack | 2019-09-01 | 0000-00-00 | No | No | Current |