FDA.reportPublic FDA data

Doxylamine succinate and Pyridoxine hydrochloride

Product NDC
69452-206
11-digit product format
694520206
Labeler code
69452
Product ID
69452-206_4527bd89-c3ee-9cfe-e063-6294a90a3ebc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxylamine succinate and Pyridoxine hydrochloride
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Bionpharma Inc.,
Application
ANDA217000
Marketing category
ANDA
Marketing start
2023-12-11
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-206-20Doxylamine succinate and Pyridoxine hydrochloride100 in 1 BOTTLETABLET, DELAYED RELEASE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-206DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE TABLET, DELAYED RELEASE [BIONPHARMA INC.,]1Current NDC, 1 package rows20231212_0c410285-0ad6-aabc-e063-6294a90abcd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1375948doxylamine succinate 10 MG / pyridoxine HCl 10 MG Delayed Release Oral TabletPSN0c410285-0ad6-aabc-e063-6294a90abcd82
1375948doxylamine succinate 10 MG / pyridoxine hydrochloride 10 MG Delayed Release Oral TabletSCD0c410285-0ad6-aabc-e063-6294a90abcd82
1375948doxylamine succinate 10 MG / vit-B6 Hydrochloride 10 MG Delayed Release Oral TabletSY0c410285-0ad6-aabc-e063-6294a90abcd82
1375948doxylamine succinate 10 MG / vitamin B6 Hydrochloride 10 MG Delayed Release Oral TabletSY0c410285-0ad6-aabc-e063-6294a90abcd82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69452-206-2069452020620100 TABLET, DELAYED RELEASE in 1 BOTTLE (69452-206-20) 2023-12-11NoNoCurrent