Doxylamine succinate and pyridoxine hydrochloride

Product NDC: 0591-2132
Requested package NDC: 0591-2132-01
11-digit product format: 005912132
Labeler code: 0591
Product ID: 0591-2132_a51f5dfd-c4ff-4fea-8a7c-1fc058cd7c11
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Doxylamine succinate and pyridoxine hydrochloride
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA205811
Marketing category: ANDA
Marketing start: 2019-06-21
Substance: DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Active strength: 10; 10 mg/1; mg/1
Pharmacologic classes: Analogs/Derivatives [Chemical/Ingredient], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB		2016-08-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A205811-001	AB

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205811-001	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	10MG;10MG	TABLET, DELAYED RELEASE / ORAL	AB	2016-08-19	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205811-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205811-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205811-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205811-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205811-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205811-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205811-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205811-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205811-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205811-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205811-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205811-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205811-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205811-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205811-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205811-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205811-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205811-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205811-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205811-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205811-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205811-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205811-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205811-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205811-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205811-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205811-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205811-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205811-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205811-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205811-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205811-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205811-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205811-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205811-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205811-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205811-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205811-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205811-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205811-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Doxylamine succinate and pyridoxine hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOXYLAMINE SUCCINATE	10 mg/1
PYRIDOXINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V9BI9B5YI2	Internal UNII lookup
68Y4CF58BV	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1375948	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3670d66e-c1e4-42ce-8760-c3d5accad925	Available on FDA.report

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
0591-2132-01	Doxylamine succinate and pyridoxine hydrochloride	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2132-01	EA - Each	0591-2132	be429eca-e8a4-4e6e-b7d4-a44bce6af53e	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2132	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20231118_3670d66e-c1e4-42ce-8760-c3d5accad925.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Doxylamine succinate and pyridoxine hydrochloride	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	Actavis Pharma, Inc.	3670d66e-c1e4-42ce-8760-c3d5accad925	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205811 application number: ANDA205811 ndc (package): 0591-2132-01 ndc (product): 0591-2132 ndc11 (package): 00591213201

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1375948	doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral Tablet	PSN	3670d66e-c1e4-42ce-8760-c3d5accad925	8
1375948	doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral Tablet	SCD	3670d66e-c1e4-42ce-8760-c3d5accad925	8
1375948	doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral Tablet	SY	3670d66e-c1e4-42ce-8760-c3d5accad925	8
1375948	doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral Tablet	SY	3670d66e-c1e4-42ce-8760-c3d5accad925	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2132-01	00591213201	100 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2132-01)	2019-06-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Doxylamine succinate and pyridoxine hydrochloride	Actavis Pharma, Inc.	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	8