Application 040564

Type: ANDA
Sponsor: LNK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DOXYLAMINE SUCCINATE	DOXYLAMINE SUCCINATE	TABLET;ORAL	25MG	No	No

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
A040564-001	DOXYLAMINE SUCCINATE	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL			2004-08-27

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040564-001	DOXYLAMINE SUCCINATE	25MG	TABLET / ORAL	2004-08-27	`cb3db0bc1861…`

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	H E B	17667c28-b61e-4974-8736-5de59f69b3b0	2026-07-09	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep-Aid	DOXYLAMINE SUCCINATE	Cardinal Health 110, LLC. DBA Leader	96e8d6df-e717-4ffc-9502-498024c9665f	2026-07-09	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564 ndc (product): 70000-0567
Nocto Sleep Aid	DOXYLAMINE SUCCINATE	Belmora LLC	d255309b-0023-48fe-890f-6a4fe04dbb85	2026-07-09	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	Amerisource Bergen	ea842bc4-9788-49a9-a7e1-d6e3dd61056a	2026-06-15	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	6d6e47df-a965-4813-8414-9841ed2f9e0c	2026-06-15	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	ARMY AND AIR FORCE EXCHANGE SERVICE	009df4c9-a524-4b8f-be7a-52c521e68ff1	2026-05-18	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	Strategic Sourcing Services LLC	eddec8bc-2bed-4bc5-a1c2-39424a699838	2026-05-13	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	Wal-Mart Stores Inc	71e0cef1-6195-4b67-9c1f-b4e5fbeae53c	2026-05-13	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	United Natural Foods, Inc. dba UNFI	005b5ad8-d762-46b5-a7a5-e0ff11ba936a	2026-04-06	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	Better Living Brands, LLC	92827089-88d5-4f4e-bcbe-3ca6d94ee96c	2026-03-27	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	Meijer Distribution Inc	96a7c284-4666-4dac-b71e-9433f62580ad	2026-03-27	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	918ad808-ccfd-429f-9052-19905a634606	2026-03-27	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Unisom SleepTabs	DOXYLAMINE SUCCINATE	Chattem, Inc.	7ae32d74-76a0-47e2-9e5c-812426413c4e	2026-03-25	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	Grocery Outlet	bc13c6c1-1706-4f8c-9789-448f7fe4628d	2026-03-18	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	Walgreen Company	d812217b-b2f2-4716-92f4-c16bd0768e17	2026-02-11	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	L.N.K. International, Inc.	8df4ac6d-f222-4218-9dcc-3df09c91d2ae	2026-01-06	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
SLEEP AID 25mg	DOXYLAMINE SUCCINATE	YYBA CORP	a436f6d2-6d7e-4f0e-b1c3-acc17cbcb64a	2025-12-02	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564 ndc (product): 73581-205
Nighttime Sleep-Aid	DOXYLAMINE SUCCINATE	Kroger Company	8b85812e-33a3-4534-bfba-ee4502d11d34	2025-09-23	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Sleep Aid	DOXYLAMINE SUCCINATE	Kroger Company	76e1e49d-eb57-4590-8cf8-91f29dbd15c3	2025-08-22	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564
Nighttime Sleep Aid	DOXYLAMINE SUCCINATE	CVS PHARMACY	0b08ca81-1d07-4a57-9cbd-72e3a6a37814	2025-08-19	Warnings	Exact identifier application applno (ANDA): 040564 application number: ANDA040564 ndc (product): 69842-386

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 112 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63981-386	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-386	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-986	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-986	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-986	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-986	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
63981-986	Sleep Aid	Doxylamine succinate	COSTCO WHOLESALE CORPORATION	ANDA	Current
64092-350	Nighttime Sleep Aid	Doxylamine succinate	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-350	Nighttime Sleep Aid	Doxylamine succinate	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
64092-350	Nighttime Sleep Aid	Doxylamine succinate	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS PHARMACY	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS PHARMACY	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS PHARMACY	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS Pharmacy	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS Pharmacy	ANDA	Current
69842-386	Nighttime Sleep Aid	Doxylamine succinate	CVS PHARMACY	ANDA	Current
70000-0249	Sleep Aid	Doxylamine succinate	Cardinal Health	ANDA	Current
70000-0249	Sleep Aid	Doxylamine succinate	Cardinal Health	ANDA	Current
70000-0567	Sleep-Aid	Doxylamine succinate	Cardinal Health 110, LLC. DBA Leader	ANDA	Current
70000-0567	Sleep-Aid	Doxylamine succinate	Cardinal Health 110, LLC. DBA Leader	ANDA	Current
70000-0567	Sleep-Aid	Doxylamine succinate	Cardinal Health 110, LLC. DBA Leader	ANDA	Current
70000-0567	Sleep-Aid	Doxylamine succinate	Cardinal Health	ANDA	Current
70677-0025	Sleep Aid	Doxylamine succinate	McKesson (Sunmark)	ANDA	Current
70677-0068	Sleep Aid	Doxylamine Succinate	Strategic Sourcing Services, LLC (Sunmark)	ANDA	Current
70677-0068	Sleep Aid	Doxylamine Succinate	Strategic Sourcing Services, LLC (Sunmark)	ANDA	Current
70677-0068	Sleep Aid	Doxylamine Succinate	Strategic Sourcing Services, LLC (Sunmark)	ANDA	Current
70677-0068	Sleep Aid	Doxylamine Succinate	Strategic Sourcing Services, LLC (Sunmark)	ANDA	Current
70677-0068	Sleep Aid	Doxylamine Succinate	McKesson (Sunmark)	ANDA	Current
73581-205	SLEEP AID	DOXYLAMINE SUCCINATE	YYBA CORP	ANDA	Current
73581-205	SLEEP AID	DOXYLAMINE SUCCINATE	YYBA CORP	ANDA	Current
73581-205	SLEEP AID	DOXYLAMINE SUCCINATE	YYBA CORP	ANDA	Current
73581-205	SLEEP AID	DOXYLAMINE SUCCINATE	YYBA CORP	ANDA	Current