Doxylamine succinate and Pyridoxine hydrochloride
These highlights do not include all the information needed to use DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE DELAYED-RELEASE TABLETS. DOXYLAMINE SUCCINATE and PYRIDOXINE HYDROCHLORIDE delayed-release tablets, for oral use Initial U.S. Approval: 1976
Approved
Approval ID
0c410285-0ad6-aabc-e063-6294a90abcd8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2023
Manufacturers
FDA
Bionpharma Inc.,
DUNS: 079637826
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxylamine succinate and Pyridoxine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69452-206
Application NumberANDA217000
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxylamine succinate and Pyridoxine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 11, 2023
FDA Product Classification
INGREDIENTS (17)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
DOXYLAMINE SUCCINATEActive
Quantity: 10 mg in 1 1
Code: V9BI9B5YI2
Classification: ACTIB
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT