azithromycin dihydrate
These highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
Approved
Approval ID
33d4ac05-b564-440c-971d-b78590dd2c32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2024
Manufacturers
FDA
Slate Run Pharmaceuticals, LLC
DUNS: 039452765
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
azithromycin dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-220
Application NumberANDA217036
Product Classification
M
Marketing Category
C73584
G
Generic Name
azithromycin dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2024
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AZITHROMYCIN DIHYDRATEActive
Quantity: 100 mg in 5 mL
Code: 5FD1131I7S
Classification: ACTIM
azithromycin dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-221
Application NumberANDA217036
Product Classification
M
Marketing Category
C73584
G
Generic Name
azithromycin dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2024
FDA Product Classification
INGREDIENTS (6)
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
AZITHROMYCIN DIHYDRATEActive
Quantity: 200 mg in 5 mL
Code: 5FD1131I7S
Classification: ACTIM
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
azithromycin dihydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-222
Application NumberANDA217036
Product Classification
M
Marketing Category
C73584
G
Generic Name
azithromycin dihydrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 29, 2024
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
AZITHROMYCIN DIHYDRATEActive
Quantity: 200 mg in 5 mL
Code: 5FD1131I7S
Classification: ACTIM