Methotrexate

Product NDC
16729-277
11-digit product format
167290277
Labeler code
16729
Product ID
16729-277_2bae3cfe-7aa0-c14c-e063-6294a90a19f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methotrexate
Dosage form
INJECTION
Route
INTRA-ARTERIAL; INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
ANDA040716
Marketing category
ANDA
Marketing start
2014-03-07
Substance
METHOTREXATE
Active strength
25 mg/mL
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEMETHOTREXATE SODIUMEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040716-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-303f01610625f2…
2019-09-15 20:21 UTC2019-09A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040716-001METHOTREXATE SODIUM PRESERVATIVE FREEEQ 1GM BASE/40ML (EQ 25MG BASE/ML)INJECTABLE / INJECTIONAPRS2007-04-30e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040716-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040716-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040716-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040716-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040716-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040716-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040716-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040716-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040716-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040716-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040716-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040716-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040716-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040716-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040716-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040716-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040716-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040716-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040716-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040716-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040716-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040716-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A040716-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040716-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040716-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040716-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A040716-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040716-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040716-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040716-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040716-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040716-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040716-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040716-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040716-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040716-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040716-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040716-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040716-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040716-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Methotrexate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOTREXATE25 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YL5FZ2Y5U1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1655956Internal RxNorm lookup
1655959Internal RxNorm lookup
1655960Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dd035a9f-cd40-4314-b9d8-2294b8a924e2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2eb9a854-4fbc-9bbe-3199-41fc1018a1f0Product name920250224
3082de91-569a-4d57-b379-acbf37f1d5c3Product name120210312
f76135bc-a210-42d9-851b-1b73cbaccdb3Product name120200511
423544b2-e325-49ee-8910-4c5dfe41906fProduct name120181120
c9fd924b-0a8d-4d53-bf70-11070e24e4ddProduct name220181120
ce1e7cc6-4850-4cb1-8dde-8010b2fbc359Product name120181120
eb454f54-2806-4c31-a08b-8dcb08261099Product name220181120
d9cebc09-c68d-46f5-bdcd-fd82e945cc27Product name120170705
16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3Product name220160504
88514aea-9d58-4ed2-b135-9811fb14c8fbProduct name120141209
0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-277-03Methotrexate1 in 1 CARTONINJECTION16
16729-277-03Methotrexate10 mL in 1 VIALINJECTION106
16729-277-30Methotrexate1 in 1 CARTONINJECTION16
16729-277-30Methotrexate2 mL in 1 VIALINJECTION26
16729-277-35Methotrexate40 mL in 1 VIALINJECTION406
16729-277-35Methotrexate1 in 1 CARTONINJECTION16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-277-03ML - Milliliter16729-277d5410565-7b82-4c8e-84ea-9bd78573206a12014-04-03
16729-277-30ML - Milliliter16729-2777f4ded3d-08d1-45af-ac05-def9c248147a12014-04-03
16729-277-35ML - Milliliter16729-27780486de1-b61e-4b26-90fd-ebf539e4158312014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOTREXATEACTIVE INGREDIENTYL5FZ2Y5U1METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]1
METHOTREXATEACTIVE MOIETYYL5FZ2Y5U1METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBMETHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMETHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IMETHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-277METHOTREXATE INJECTION [ACCORD HEALTHCARE, INC.]6Current NDC, Legacy NDC, 6 package rows20250116_dd035a9f-cd40-4314-b9d8-2294b8a924e2.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MethotrexateMETHOTREXATEAccord Healthcare, Inc.dd035a9f-cd40-4314-b9d8-2294b8a924e22025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040716
application number: ANDA040716
ndc (product): 16729-277

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1655956methotrexate 1 GM in 40 ML InjectionPSNdd035a9f-cd40-4314-b9d8-2294b8a924e26
1655959methotrexate 250 MG in 10 ML InjectionPSNdd035a9f-cd40-4314-b9d8-2294b8a924e26
1655960methotrexate 50 MG in 2 ML InjectionPSNdd035a9f-cd40-4314-b9d8-2294b8a924e26
165595910 ML methotrexate 25 MG/ML InjectionSCDdd035a9f-cd40-4314-b9d8-2294b8a924e26
16559602 ML methotrexate 25 MG/ML InjectionSCDdd035a9f-cd40-4314-b9d8-2294b8a924e26
165595640 ML methotrexate 25 MG/ML InjectionSCDdd035a9f-cd40-4314-b9d8-2294b8a924e26
1655956methotrexate 1 GM per 40 ML InjectionSYdd035a9f-cd40-4314-b9d8-2294b8a924e26
1655959methotrexate 250 MG per 10 ML InjectionSYdd035a9f-cd40-4314-b9d8-2294b8a924e26
1655960methotrexate 50 MG per 2 ML InjectionSYdd035a9f-cd40-4314-b9d8-2294b8a924e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-277-03167290277031 VIAL in 1 CARTON (16729-277-03) / 10 mL in 1 VIAL1 vial2014-03-070000-00-00NoNoCurrent
16729-277-30167290277301 VIAL in 1 CARTON (16729-277-30) / 2 mL in 1 VIAL1 vial2014-03-070000-00-00NoNoCurrent
16729-277-35167290277351 VIAL in 1 CARTON (16729-277-35) / 40 mL in 1 VIAL1 vial2014-03-070000-00-00NoNoCurrent