Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Wockhardt Bio AG
483165838
Manufacturing Establishments5
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Sanofie Chimie, Sisteron, France
Wockhardt USA LLC.
Wockhardt Bio AG
262600765
Divis Laboratories Limited
Wockhardt USA LLC.
Wockhardt Bio AG
918598199
Halo Pharmaceutical Canada Inc.
Wockhardt USA LLC.
Wockhardt Bio AG
250928632
Aurobindo Pharma Limited, Andhra Pradesh, India
Wockhardt USA LLC.
Wockhardt Bio AG
918917626
Neopharm Labs Inc.
Wockhardt USA LLC.
Wockhardt Bio AG
243379372
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Promethazine Hydrochloride and Dextromethorphan Hydrobromide
Product Details
NDC Product Code
64679-604Application Number
ANDA088864Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 20, 2023WATERInactive
Code: 059QF0KO0RClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42INClass: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
PromethazineActive
Code: R61ZEH7I1IClass: ACTIBQuantity: 6.25 mg in 5 mL
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
DextromethorphanActive
Code: 9D2RTI9KYHClass: ACTIBQuantity: 15 mg in 5 mL