Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Nostrum Laboratories, Inc.
791055549
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Nostrum Laboratories, Inc.
Nostrum Laboratories, Inc.
Nostrum Laboratories, Inc.
791055549
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROMETHAZINE HYDROCHLORIDE
Product Details
NDC Product Code
70408-146Application Number
ANDA040891Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 18, 2024SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULRClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
PromethazineActive
Code: R61ZEH7I1IClass: ACTIBQuantity: 6.25 mg in 5 mL
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT