MedPath

Acetazolamide

Acetazolamide Extended-release Capsules

Approved
Approval ID

58e87a73-0abc-4bd7-9f53-0eace0fe9a11

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 1, 2022

Manufacturers
FDA

Nostrum Laboratories, Inc.

DUNS: 791142354

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Acetazolamide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code29033-030
Application NumberANDA204691
Product Classification
M
Marketing Category
C73584
G
Generic Name
Acetazolamide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2018
FDA Product Classification

INGREDIENTS (19)

ACETAZOLAMIDEActive
Quantity: 500 mg in 1 1
Code: O3FX965V0I
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

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