Azithromycin
Azithromycin for Oral Suspension USP 7148 7149 Rx only
Approved
Approval ID
4e9ac94f-4d85-4731-8b7f-6188209b4a9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 16, 2013
Manufacturers
FDA
MedVantx, Inc.
DUNS: 806427725
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Azithromycin Monohydrate
PRODUCT DETAILS
NDC Product Code66116-524
Application NumberANDA065419
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 16, 2013
Generic NameAzithromycin Monohydrate
INGREDIENTS (10)
AZITHROMYCIN MONOHYDRATEActive
Quantity: 200 mg in 5 mL
Code: JTE4MNN1MD
Classification: ACTIM
ETHYL VANILLINInactive
Code: YC9ST449YJ
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATEInactive
Code: B70850QPHR
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT