Home NDC 0642-7470 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 0642-7470-03 excluded package package 0642-7470-06 excluded package package 0642-7470-02
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211367-001 SLYND DROSPIRENONE 4MG TABLET / ORAL RLD, RS 2019-05-23
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211367-001 10179140 2031-06-28 U-2553 2019-06-24 N211367-001 10603281 2031-06-28 U-2553 2020-04-03 N211367-001 10849857 2031-06-28 U-2553 Drug product 2020-12-08 N211367-001 10987364 2031-06-28 Drug product 2021-04-30 N211367-001 11123299 2031-06-28 Drug product 2021-10-04 N211367-001 11291632 2031-06-28 Drug product 2022-04-11 N211367-001 11291633 2031-06-28 Drug product 2022-04-11 N211367-001 11351122 2031-06-28 Drug product 2022-06-09 N211367-001 11413249 2031-06-28 U-2553 2022-08-22 N211367-001 11478487 2031-06-28 Drug product 2022-11-04 N211367-001 11504334 2031-06-28 Drug product 2022-12-16 N211367-001 11951213 2031-06-28 U-2553 2024-04-25 N211367-001 12090231 2031-06-28 U-2553 2024-10-09 N211367-001 12280151 2031-06-28 Drug product 2025-05-08 N211367-001 9603860 2031-06-28 U-2553 2019-07-03
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211367-001 SLYND 4MG TABLET / ORAL AB RLD, RS 2019-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211367-001 SLYND 4MG TABLET / ORAL AB RLD, RS 2019-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211367-001 SLYND 4MG TABLET / ORAL AB RLD, RS 2019-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211367-001 SLYND 4MG TABLET / ORAL RLD, RS 2019-05-23 cb3db0bc1861…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211367-001 AB 1 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211367-001 AB 1 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211367-001 AB 1 d06236e962d9…
Observed Orange Book patent history# Patent history page 1 of 11 · 434 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211367-001 10179140 2031-06-28 U-2553 2019-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 10603281 2031-06-28 U-2553 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 10849857 2031-06-28 U-2553 Drug product 2020-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 10987364 2031-06-28 Drug product 2021-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 11123299 2031-06-28 Drug product 2021-10-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 11291632 2031-06-28 Drug product 2022-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 11291633 2031-06-28 Drug product 2022-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 11351122 2031-06-28 Drug product 2022-06-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 11413249 2031-06-28 U-2553 2022-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 11478487 2031-06-28 Drug product 2022-11-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 11504334 2031-06-28 Drug product 2022-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 11951213 2031-06-28 U-2553 2024-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 12090231 2031-06-28 U-2553 2024-10-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 12280151 2031-06-28 Drug product 2025-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211367-001 9603860 2031-06-28 U-2553 2019-07-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 10179140 2031-06-28 U-2553 2019-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 10603281 2031-06-28 U-2553 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 10849857 2031-06-28 U-2553 Drug product 2020-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 10987364 2031-06-28 Drug product 2021-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 11123299 2031-06-28 Drug product 2021-10-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 11291632 2031-06-28 Drug product 2022-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 11291633 2031-06-28 Drug product 2022-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 11351122 2031-06-28 Drug product 2022-06-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 11413249 2031-06-28 U-2553 2022-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 11478487 2031-06-28 Drug product 2022-11-04 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 11504334 2031-06-28 Drug product 2022-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 11951213 2031-06-28 U-2553 2024-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 12090231 2031-06-28 U-2553 2024-10-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 12280151 2031-06-28 Drug product 2025-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211367-001 9603860 2031-06-28 U-2553 2019-07-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211367-001 10179140 2031-06-28 U-2553 2019-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211367-001 10603281 2031-06-28 U-2553 2020-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211367-001 10849857 2031-06-28 U-2553 Drug product 2020-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211367-001 10987364 2031-06-28 Drug product 2021-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211367-001 11123299 2031-06-28 Drug product 2021-10-04 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211367-001 11291632 2031-06-28 Drug product 2022-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211367-001 11291633 2031-06-28 Drug product 2022-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211367-001 11351122 2031-06-28 Drug product 2022-06-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211367-001 11413249 2031-06-28 U-2553 2022-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211367-001 11478487 2031-06-28 Drug product 2022-11-04 6a471c1ec25d…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base SLYND
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 748797 Internal RxNorm lookup 2171000 Internal RxNorm lookup 2171001 Internal RxNorm lookup 2171002 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 0642-7470-01 2024-08-07 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 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 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 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 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 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 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 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 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 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 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 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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