Tacrolimus
These highlights do not include all the information needed to use TACROLIMUS CAPSULES safely and effectively. See full prescribing information for TACROLIMUS CAPSULES. TACROLIMUS capsules, for oral use Initial U.S. Approval: 1994
Approved
Approval ID
55467f4b-8437-43a3-b6d9-1bc2a13b4c11
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2023
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tacrolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-279
Application NumberANDA203740
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tacrolimus
Product Specifications
Route of AdministrationORAL
Effective DateMarch 28, 2023
FDA Product Classification
INGREDIENTS (8)
TACROLIMUSActive
Quantity: 1 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Tacrolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-280
Application NumberANDA203740
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tacrolimus
Product Specifications
Route of AdministrationORAL
Effective DateMarch 28, 2023
FDA Product Classification
INGREDIENTS (9)
TACROLIMUSActive
Quantity: 5 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Tacrolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-278
Application NumberANDA203740
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tacrolimus
Product Specifications
Route of AdministrationORAL
Effective DateMarch 28, 2023
FDA Product Classification
INGREDIENTS (9)
TACROLIMUSActive
Quantity: 0.5 mg in 1 1
Code: WM0HAQ4WNM
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT