Azithromycin
These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
Approved
Approval ID
9c44af6d-8a9a-cb4c-e053-2a95a90afdac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2023
Manufacturers
FDA
Asclemed USA, Inc.
DUNS: 059888437
Products 2
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 Code76420-589
Application NumberANDA065223
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azithromycin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
AZITHROMYCIN MONOHYDRATEActive
Quantity: 500 mg in 1 1
Code: JTE4MNN1MD
Classification: ACTIM
Azithromycin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76420-006
Application NumberANDA065225
Product Classification
M
Marketing Category
C73584
G
Generic Name
Azithromycin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2023
FDA Product Classification
INGREDIENTS (12)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
AZITHROMYCIN MONOHYDRATEActive
Quantity: 250 mg in 1 1
Code: JTE4MNN1MD
Classification: ACTIM