AZITHROMYCIN
Approved
Approval ID
6307a49b-753a-4232-a51d-bf6d0537b05b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
AZITHROMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-838
Application NumberANDA065404
Product Classification
M
Marketing Category
C73584
G
Generic Name
AZITHROMYCIN
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2012
FDA Product Classification
INGREDIENTS (1)
AZITHROMYCIN ANHYDROUSActive
Quantity: 250 mg in 1 1
Code: J2KLZ20U1M
Classification: ACTIM