FDA.reportPublic FDA data

Doxylamine succinate and pyridoxine hydrochloride

Product NDC
70505-100
11-digit product format
705050100
Labeler code
70505
Product ID
70505-100_59e091eb-f626-4083-b134-8d648d28b918
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxylamine succinate and pyridoxine hydrochloride
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Analog Pharma
Application
NDA021876
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-11-15
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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70505-100-10Doxylamine 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
70505-100-10EA - Each70505-1005ca605b3-340b-42de-8103-3f1aa93fbcb112019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70505-100DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE [ANALOG PHARMA]7Current NDC, Legacy NDC, 1 package rows20241219_76d10d65-0279-4e86-8104-cade4343f839.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1375948doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral TabletPSN76d10d65-0279-4e86-8104-cade4343f8398
1375948doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral TabletSCD76d10d65-0279-4e86-8104-cade4343f8398
1375948doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral TabletSY76d10d65-0279-4e86-8104-cade4343f8398
1375948doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral TabletSY76d10d65-0279-4e86-8104-cade4343f8398

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70505-100-1070505010010100 TABLET, DELAYED RELEASE in 1 BOTTLE (70505-100-10) 2018-11-150000-00-00NoNoCurrent