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
NDC Product Code69452-206
Application NumberANDA217000
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 11, 2023
Generic NameDoxylamine succinate and Pyridoxine hydrochloride
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