FDA.reportPublic FDA data

BONJESTA

Product NDC
55494-120
11-digit product format
554940120
Labeler code
55494
Product ID
55494-120_3e4fbcb3-ac64-4673-b46f-a2ce616d4374
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
doxylamine succinate and pyridoxine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Duchesnay USA, Inc.
Application
NDA209661
Marketing category
NDA
Marketing start
2018-02-19
Substance
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
Active strength
20; 20 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
BONJESTA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE20 mg/1
PYRIDOXINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV9BI9B5YI2, 68Y4CF58BV
Rxcui1999651, 1999657

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55494-120-10BONJESTA100 in 1 BOTTLETABLET, EXTENDED RELEASE10013
55494-120-60BONJESTA60 in 1 BOTTLETABLET, EXTENDED RELEASE6013
55494-120-94BONJESTA4 in 1 BLISTER PACKTABLET, EXTENDED RELEASE413
55494-120-94BONJESTA1 in 1 CARTONTABLET, EXTENDED RELEASE113
55494-120-99BONJESTA6 in 1 BOTTLETABLET, EXTENDED RELEASE613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55494-120-60EA - Each55494-120d8a4e26f-4af1-4541-9228-c09496a1284d12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55494-120BONJESTA (DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [DUCHESNAY USA, INC.]13Current NDC, Legacy NDC, 5 package rows20250228_dba60bb4-54ff-4e06-b8d2-acbbd3717666.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999657Bonjesta 20 MG / 20 MG 12HR Extended Release Oral TabletPSNdba60bb4-54ff-4e06-b8d2-acbbd371766613
1999651doxylamine succinate 20 MG / pyridoxine HCl 12HR 20 MG Extended Release Oral TabletPSNdba60bb4-54ff-4e06-b8d2-acbbd371766613
199965712 HR doxylamine succinate 20 MG / pyridoxine hydrochloride 20 MG Extended Release Oral Tablet [Bonjesta]SBDdba60bb4-54ff-4e06-b8d2-acbbd371766613
199965112 HR doxylamine succinate 20 MG / pyridoxine hydrochloride 20 MG Extended Release Oral TabletSCDdba60bb4-54ff-4e06-b8d2-acbbd371766613
199965112 HR doxylamine succinate 20 MG / vit-B6 Hydrochloride 20 MG Extended Release Oral TabletSYdba60bb4-54ff-4e06-b8d2-acbbd371766613
199965712 HR doxylamine succinate 20 MG / vit-B6 Hydrochloride 20 MG Extended Release Oral Tablet [Bonjesta]SYdba60bb4-54ff-4e06-b8d2-acbbd371766613
199965112 HR doxylamine succinate 20 MG / vitamin B6 Hydrochloride 20 MG Extended Release Oral TabletSYdba60bb4-54ff-4e06-b8d2-acbbd371766613
199965712 HR doxylamine succinate 20 MG / vitamin B6 Hydrochloride 20 MG Extended Release Oral Tablet [Bonjesta]SYdba60bb4-54ff-4e06-b8d2-acbbd371766613
1999657Bonjesta 20 MG / 20 MG 12HR Extended Release Oral TabletSYdba60bb4-54ff-4e06-b8d2-acbbd371766613
1999651doxylamine succinate 20 MG / pyridoxine hydrochloride 12 HR 20 MG Extended Release Oral TabletSYdba60bb4-54ff-4e06-b8d2-acbbd371766613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55494-120-1055494012010100 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-10) 2018-02-190000-00-00NoNoCurrent
55494-120-605549401206060 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-60) 2018-02-190000-00-00NoNoCurrent
55494-120-94554940120941 BLISTER PACK in 1 CARTON (55494-120-94) / 4 TABLET, EXTENDED RELEASE in 1 BLISTER PACK1 blister pack2025-02-26YesNoCurrent
55494-120-99554940120996 TABLET, EXTENDED RELEASE in 1 BOTTLE (55494-120-99) 2018-02-190000-00-00YesNoCurrent