Doxylamine Succinate and Pyridoxine Hydrochloride

Product NDC: 0378-4615
Requested package NDC: 0378-4615-01
11-digit product format: 003784615
Labeler code: 0378
Product ID: 0378-4615_0e21f33d-1f0c-45be-b5f7-cc0b8888c511
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: doxylamine succinate and pyridoxine hydrochloride
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA207825
Marketing category: ANDA
Marketing start: 2020-07-21
Marketing end: 0000-00-00
Substance: DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Active strength: 10 mg/1; mg/1
Pharmacologic classes: Antihistamine [EPC],Histamine Receptor Antagonists [MoA],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0378-4615	0378-4615-01	D	Discontinued by firm		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL			2020-07-06

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL		2020-07-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL		2020-07-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2020-07-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A207825-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL		2020-07-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207825-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207825-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207825-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207825-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207825-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207825-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207825-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207825-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207825-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207825-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207825-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207825-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207825-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207825-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207825-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207825-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207825-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A207825-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207825-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207825-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207825-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207825-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207825-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A207825-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A207825-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A207825-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A207825-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A207825-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A207825-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A207825-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A207825-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A207825-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A207825-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A207825-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A207825-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A207825-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0378-4615-01	Doxylamine Succinate and Pyridoxine Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-4615-01	EA - Each	0378-4615	586f70d2-c993-4924-894f-caef1d7819f5	1	2020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-4615	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS INC.]	4	Legacy NDC, 1 package rows	20250119_957865a2-efcf-43a6-92a8-f9f980892833.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE
68Y4CF58BV	PYRIDOXINE HYDROCHLORIDE	58-56-0	PYRIDOXINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-4615-01	00378461501	100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0378-4615-01)	2020-07-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxylamine Succinate and Pyridoxine Hydrochloride	Mylan Pharmaceuticals Inc.	2022-11-30	HUMAN PRESCRIPTION DRUG LABEL	5