Home NDC 51285-367 Trexall
Product NDC 51285-367
11-digit product format 512850367
Labeler code 51285
Product ID 51285-367_6743bd6d-9c6b-4f43-b444-8faa4b5d5221
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methotrexate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Women's Health, Inc.
Application ANDA040385
Marketing category ANDA
Marketing start 2001-05-03
Substance METHOTREXATE SODIUM
Active strength 7.5 mg/1
Pharmacologic classes Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040385-001 TREXALL METHOTREXATE SODIUM EQ 5MG BASE TABLET / ORAL 2001-03-21 A040385-002 TREXALL METHOTREXATE SODIUM EQ 7.5MG BASE TABLET / ORAL 2001-03-21 A040385-003 TREXALL METHOTREXATE SODIUM EQ 10MG BASE TABLET / ORAL 2001-03-21 A040385-004 TREXALL METHOTREXATE SODIUM EQ 15MG BASE TABLET / ORAL RS 2001-03-21
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 168 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A040385-001 TREXALL EQ 5MG BASE TABLET / ORAL 2001-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040385-002 TREXALL EQ 7.5MG BASE TABLET / ORAL 2001-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040385-003 TREXALL EQ 10MG BASE TABLET / ORAL 2001-03-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040385-004 TREXALL EQ 15MG BASE TABLET / ORAL RS 2001-03-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040385-001 TREXALL EQ 5MG BASE TABLET / ORAL 2001-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040385-002 TREXALL EQ 7.5MG BASE TABLET / ORAL 2001-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040385-003 TREXALL EQ 10MG BASE TABLET / ORAL 2001-03-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040385-004 TREXALL EQ 15MG BASE TABLET / ORAL RS 2001-03-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040385-001 TREXALL EQ 5MG BASE TABLET / ORAL 2001-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040385-002 TREXALL EQ 7.5MG BASE TABLET / ORAL 2001-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040385-003 TREXALL EQ 10MG BASE TABLET / ORAL 2001-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040385-004 TREXALL EQ 15MG BASE TABLET / ORAL RS 2001-03-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040385-001 TREXALL EQ 5MG BASE TABLET / ORAL 2001-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040385-002 TREXALL EQ 7.5MG BASE TABLET / ORAL 2001-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040385-003 TREXALL EQ 10MG BASE TABLET / ORAL 2001-03-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040385-004 TREXALL EQ 15MG BASE TABLET / ORAL RS 2001-03-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040385-001 TREXALL EQ 5MG BASE TABLET / ORAL 2001-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040385-002 TREXALL EQ 7.5MG BASE TABLET / ORAL 2001-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040385-003 TREXALL EQ 10MG BASE TABLET / ORAL 2001-03-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040385-004 TREXALL EQ 15MG BASE TABLET / ORAL RS 2001-03-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040385-001 TREXALL EQ 5MG BASE TABLET / ORAL 2001-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040385-002 TREXALL EQ 7.5MG BASE TABLET / ORAL 2001-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040385-003 TREXALL EQ 10MG BASE TABLET / ORAL 2001-03-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040385-004 TREXALL EQ 15MG BASE TABLET / ORAL RS 2001-03-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040385-001 TREXALL EQ 5MG BASE TABLET / ORAL 2001-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040385-002 TREXALL EQ 7.5MG BASE TABLET / ORAL 2001-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040385-003 TREXALL EQ 10MG BASE TABLET / ORAL 2001-03-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040385-004 TREXALL EQ 15MG BASE TABLET / ORAL RS 2001-03-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040385-001 TREXALL EQ 5MG BASE TABLET / ORAL 2001-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040385-002 TREXALL EQ 7.5MG BASE TABLET / ORAL 2001-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040385-003 TREXALL EQ 10MG BASE TABLET / ORAL 2001-03-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040385-004 TREXALL EQ 15MG BASE TABLET / ORAL RS 2001-03-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040385-001 TREXALL EQ 5MG BASE TABLET / ORAL 2001-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040385-002 TREXALL EQ 7.5MG BASE TABLET / ORAL 2001-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040385-003 TREXALL EQ 10MG BASE TABLET / ORAL 2001-03-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040385-004 TREXALL EQ 15MG BASE TABLET / ORAL RS 2001-03-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040385-001 TREXALL EQ 5MG BASE TABLET / ORAL 2001-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040385-002 TREXALL EQ 7.5MG BASE TABLET / ORAL 2001-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040385-003 TREXALL EQ 10MG BASE TABLET / ORAL 2001-03-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040385-004 TREXALL EQ 15MG BASE TABLET / ORAL RS 2001-03-21 d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base Trexall
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOTREXATE SODIUM 7.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3IG1E710ZN Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 105586 Internal RxNorm lookup 283510 Internal RxNorm lookup 283511 Internal RxNorm lookup 283671 Internal RxNorm lookup 284592 Internal RxNorm lookup 284593 Internal RxNorm lookup 284594 Internal RxNorm lookup 284595 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51285-367-01 Trexall 30 in 1 BOTTLE TABLET, FILM COATED 30 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHOTREXATE SODIUM ACTIVE INGREDIENT 3IG1E710ZN TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 METHOTREXATE ACTIVE MOIETY YL5FZ2Y5U1 TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 SODIUM CARBONATE MONOHYDRATE INACTIVE INGREDIENT 2A1Q1Q3557 TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51285-367 TREXALL (METHOTREXATE) TABLET, FILM COATED [TEVA WOMEN'S HEALTH, INC.] 12 Current NDC, Legacy NDC, 1 package rows 20221001_e942f8db-510f-44d6-acb5-b822196f5e8c.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trexall METHOTREXATE Teva Women's Health LLC e942f8db-510f-44d6-acb5-b822196f5e8c 2026-06-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 040385 application number: ANDA040385 ndc (product): 51285-367
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51285-367-01 51285036701 30 TABLET, FILM COATED in 1 BOTTLE (51285-367-01) 2001-05-03 0000-00-00 No No Current