FDA.reportPublic FDA data

Doxylamine succinate and pyridoxine hydrochloride

Product NDC
0591-2132
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

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
0591-2132-01Doxylamine succinate and pyridoxine hydrochloride100 in 1 BOTTLETABLET, DELAYED RELEASE1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2132-01EA - Each0591-2132be429eca-e8a4-4e6e-b7d4-a44bce6af53e12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2132DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE [ACTAVIS PHARMA, INC.]7Current NDC, Legacy NDC, 1 package rows20231118_3670d66e-c1e4-42ce-8760-c3d5accad925.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1375948doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral TabletPSN3670d66e-c1e4-42ce-8760-c3d5accad9258
1375948doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral TabletSCD3670d66e-c1e4-42ce-8760-c3d5accad9258
1375948doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral TabletSY3670d66e-c1e4-42ce-8760-c3d5accad9258
1375948doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral TabletSY3670d66e-c1e4-42ce-8760-c3d5accad9258

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-2132-0100591213201100 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2132-01) 2019-06-210000-00-00NoNoCurrent