Home NDC 0555-0572 Methotrexate
Product NDC 0555-0572
11-digit product format 005550572
Labeler code 0555
Product ID 0555-0572_c21629c1-6adf-4f56-9a95-a7ec698a2e6f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methotrexate
Dosage form TABLET
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA081099
Marketing category ANDA
Marketing start 1990-11-01
Substance METHOTREXATE SODIUM
Active strength 2.5 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A081099-001 METHOTREXATE SODIUM METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A081099-001 AB
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 2 · 42 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 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A081099-001 METHOTREXATE SODIUM EQ 2.5MG BASE TABLET / ORAL AB 1990-10-15 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Methotrexate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOTREXATE SODIUM 2.5 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 105585 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 0555-0572-02 Methotrexate 100 in 1 BOTTLE TABLET 100 15 0555-0572-35 Methotrexate 36 in 1 BOTTLE TABLET 36 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHOTREXATE SODIUM ACTIVE INGREDIENT 3IG1E710ZN METHOTREXATE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 4 METHOTREXATE SODIUM ACTIVE INGREDIENT 3IG1E710ZN METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 METHOTREXATE SODIUM ACTIVE INGREDIENT 3IG1E710ZN METHOTREXATE TABLET [BARR LABORATORIES INC.] 4 METHOTREXATE ACTIVE MOIETY YL5FZ2Y5U1 METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 METHOTREXATE ACTIVE MOIETY YL5FZ2Y5U1 METHOTREXATE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 4 METHOTREXATE ACTIVE MOIETY YL5FZ2Y5U1 METHOTREXATE TABLET [BARR LABORATORIES INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METHOTREXATE TABLET [BARR LABORATORIES INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METHOTREXATE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHOTREXATE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHOTREXATE TABLET [BARR LABORATORIES INC.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METHOTREXATE TABLET [BARR LABORATORIES INC.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHOTREXATE TABLET [BARR LABORATORIES INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHOTREXATE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A METHOTREXATE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METHOTREXATE TABLET [BARR LABORATORIES INC.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METHOTREXATE TABLET [BARR LABORATORIES INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METHOTREXATE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 4 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 SODIUM CARBONATE MONOHYDRATE INACTIVE INGREDIENT 2A1Q1Q3557 METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 SODIUM CARBONATE MONOHYDRATE INACTIVE INGREDIENT 2A1Q1Q3557 METHOTREXATE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 4 SODIUM CARBONATE MONOHYDRATE INACTIVE INGREDIENT 2A1Q1Q3557 METHOTREXATE TABLET [BARR LABORATORIES INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHOTREXATE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHOTREXATE TABLET [BARR LABORATORIES INC.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U METHOTREXATE SODIUM TABLET [PHYSICIANS TOTAL CARE, INC.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U METHOTREXATE TABLET [BARR LABORATORIES INC.] 4 methotrexate sodium ACTIVE INGREDIENT 3IG1E710ZN METHOTREXATE (METHOTREXATE SODIUM) TABLET [REBEL DISTRIBUTORS CORP] 2 methotrexate ACTIVE MOIETY YL5FZ2Y5U1 METHOTREXATE (METHOTREXATE SODIUM) TABLET [REBEL DISTRIBUTORS CORP] 2 METHOTREXATE SODIUM ACTIVE INGREDIENT 3IG1E710ZN METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.] 1 METHOTREXATE ACTIVE MOIETY YL5FZ2Y5U1 METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.] 1 SODIUM CARBONATE MONOHYDRATE INACTIVE INGREDIENT 2A1Q1Q3557 METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U METHOTREXATE (METHOTREXATE) TABLET [AVKARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0555-0572 METHOTREXATE TABLET [TEVA PHARMACEUTICALS USA, INC.] 14 Current NDC, Legacy NDC, 2 package rows 20240214_9b34b1d8-d125-41a2-9f6f-3fab67b573bd.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Methotrexate METHOTREXATE AvKARE 757d6cef-6696-7a1c-8074-01258aaa8bdd 2026-07-23 Boxed warning, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099 Methotrexate METHOTREXATE Teva Pharmaceuticals USA, Inc. 9b34b1d8-d125-41a2-9f6f-3fab67b573bd 2026-06-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099 ndc (product): 0555-0572 Methotrexate METHOTREXATE A-S Medication Solutions 22e10810-16fb-4c84-bccf-972405b77ef8 2026-02-04 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099 Methotrexate METHOTREXATE Bryant Ranch Prepack e6611304-4622-4b2e-9b94-57fbad023ae2 2024-10-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 081099 application number: ANDA081099
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0555-0572-02 00555057202 100 TABLET in 1 BOTTLE (0555-0572-02) 100 tablet 1990-11-01 0000-00-00 No No Current 0555-0572-35 00555057235 36 TABLET in 1 BOTTLE (0555-0572-35) 36 tablet 1990-11-01 0000-00-00 No No Current