Trexall
{'content': [{'@styleCode': 'bold', 'content': {'@styleCode': 'bold', 'sup': '®', '#text': 'These highlights do not include all the information needed to use TREXALL safely and effectively. See full prescribing information for TREXALL.'}}, {'@styleCode': 'bold', 'content': {'@styleCode': 'bold', 'sup': '®', '#text': 'TREXALL (methotrexate tablets), for oral use'}}, {'@styleCode': 'bold', 'content': {'@styleCode': 'bold', '#text': 'Initial U.S. Approval: 1953'}}], 'br': [None, None, None]}
Approved
Approval ID
e942f8db-510f-44d6-acb5-b822196f5e8c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2021
Manufacturers
FDA
Teva Women's Health, Inc.
DUNS: 017038951
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51285-366
Application NumberANDA040385
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methotrexate
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2021
FDA Product Classification
INGREDIENTS (16)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
METHOTREXATE SODIUMActive
Quantity: 5 mg in 1 1
Code: 3IG1E710ZN
Classification: ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM CARBONATE MONOHYDRATEInactive
Code: 2A1Q1Q3557
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51285-368
Application NumberANDA040385
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methotrexate
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2021
FDA Product Classification
INGREDIENTS (14)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
METHOTREXATE SODIUMActive
Quantity: 10 mg in 1 1
Code: 3IG1E710ZN
Classification: ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SODIUM CARBONATE MONOHYDRATEInactive
Code: 2A1Q1Q3557
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51285-367
Application NumberANDA040385
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methotrexate
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2021
FDA Product Classification
INGREDIENTS (14)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
METHOTREXATE SODIUMActive
Quantity: 7.5 mg in 1 1
Code: 3IG1E710ZN
Classification: ACTIM
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM CARBONATE MONOHYDRATEInactive
Code: 2A1Q1Q3557
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Methotrexate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51285-369
Application NumberANDA040385
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methotrexate
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2021
FDA Product Classification
INGREDIENTS (15)
METHOTREXATE SODIUMActive
Quantity: 15 mg in 1 1
Code: 3IG1E710ZN
Classification: ACTIM
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM CARBONATE MONOHYDRATEInactive
Code: 2A1Q1Q3557
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2--ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT