FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiV9BI9B5YI2, 68Y4CF58BV
Rxcui1375948

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

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