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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66116-524
Application NumberANDA065419
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azithromycin Monohydrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 16, 2013
FDA Product Classification
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