Azithromycin
AZITHROMYCIN FOR ORAL SUSPENSION, USP71487149Rx only
Approved
Approval ID
58b72e4c-f419-4a70-b894-93a5804d9993
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 9, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azithromycin monohydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-549
Application NumberANDA065419
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azithromycin monohydrate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2008
FDA Product Classification
INGREDIENTS (8)
azithromycin monohydrateActive
Quantity: 200 mg in 5 mL
Code: JTE4MNN1MD
Classification: ACTIB
ethyl vanillinInactive
Code: YC9ST449YJ
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEInactive
Code: B70850QPHR
Classification: IACT
vanillinInactive
Code: CHI530446X
Classification: IACT
Azithromycin monohydrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-548
Application NumberANDA065419
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azithromycin monohydrate
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2008
FDA Product Classification
INGREDIENTS (8)
azithromycin monohydrateActive
Quantity: 100 mg in 5 mL
Code: JTE4MNN1MD
Classification: ACTIB
ethyl vanillinInactive
Code: YC9ST449YJ
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEInactive
Code: B70850QPHR
Classification: IACT
vanillinInactive
Code: CHI530446X
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT