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.
791142354
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetazolamide
Product Details
NDC Product Code
29033-030Application Number
ANDA204691Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 18, 2018AcetazolamideActive
Code: O3FX965V0IClass: ACTIBQuantity: 500 mg in 1 1
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CPClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
AMMONIAInactive
Code: 5138Q19F1XClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT