Doxylamine Succinate and Pyridoxine Hydrochloride

Product NDC
63629-2184
11-digit product format
636292184
Labeler code
63629
Product ID
63629-2184_aaf58415-1e55-4d24-ae46-d16708f4c0b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxylamine Succinate and Pyridoxine Hydrochloride, Delayed release Tablets 10 mg/10 mg
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA208518
Marketing category
ANDA
Marketing start
2019-12-19
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDEDOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208518-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-063f01610625f2…
2019-09-15 20:21 UTC2019-09A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208518-001DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE10MG;10MGTABLET, DELAYED RELEASE / ORALAB2017-12-06cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208518-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208518-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208518-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208518-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208518-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208518-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208518-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208518-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208518-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208518-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208518-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208518-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208518-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208518-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208518-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208518-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208518-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208518-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208518-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208518-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208518-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208518-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208518-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208518-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208518-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208518-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208518-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208518-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208518-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208518-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208518-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208518-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208518-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208518-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208518-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208518-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208518-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208518-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208518-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208518-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Doxylamine Succinate and Pyridoxine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE10 mg/1
PYRIDOXINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V9BI9B5YI2Internal UNII lookup
68Y4CF58BVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c283720d-f9a5-471f-9616-853a70f2b31dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2184-1Doxylamine Succinate and Pyridoxine Hydrochloride100 in 1 BOTTLETABLET, DELAYED RELEASE100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2184-1EA - Each63629-21841889feae-ab11-49f4-906b-413039e2382f12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2184DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MG) TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20231205_c283720d-f9a5-471f-9616-853a70f2b31d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doxylamine Succinate and Pyridoxine HydrochlorideDOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MGBryant Ranch Prepackc283720d-f9a5-471f-9616-853a70f2b31d2023-12-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208518
application number: ANDA208518
ndc (product): 63629-2184
Doxylamine Succinate and Pyridoxine HydrochlorideDOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MGBryant Ranch Prepack172f1b4f-4b9f-4ba4-97f6-769cfec6e0d72023-08-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208518
application number: ANDA208518
Doxylamine Succinate and Pyridoxine HydrochlorideDOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE, DELAYED RELEASE TABLETS 10 MG/10 MGEndo USA, Inc.de265fd1-bc22-4da1-aab5-b5fedd649c8b2019-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208518
application number: ANDA208518

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1375948doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral TabletPSNc283720d-f9a5-471f-9616-853a70f2b31d102
1375948doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral TabletSCDc283720d-f9a5-471f-9616-853a70f2b31d102
1375948doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral TabletSYc283720d-f9a5-471f-9616-853a70f2b31d102
1375948doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral TabletSYc283720d-f9a5-471f-9616-853a70f2b31d102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2184-163629218401100 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-2184-1) 2021-03-120000-00-00NoNoCurrent