Methotrexate

Product NDC: 16729-486
11-digit product format: 167290486
Labeler code: 16729
Product ID: 16729-486_424d715c-25c3-6376-e063-6294a90a2ef4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methotrexate
Dosage form: TABLET
Route: ORAL
Labeler: Accord Healthcare Inc.
Application: ANDA213343
Marketing category: ANDA
Marketing start: 2020-08-24
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
A213343-001	METHOTREXATE SODIUM	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB		2020-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213343-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213343-001	METHOTREXATE SODIUM	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-01-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213343-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213343-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213343-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213343-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213343-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213343-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213343-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213343-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213343-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213343-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213343-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213343-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213343-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213343-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213343-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213343-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213343-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213343-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213343-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213343-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213343-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213343-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213343-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213343-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213343-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213343-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213343-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213343-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213343-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213343-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213343-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213343-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213343-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213343-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213343-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213343-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213343-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213343-001	AB	1	`a50c72e98297…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
874c7f43-a3be-4236-89cc-24c44e3c5813	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2eb9a854-4fbc-9bbe-3199-41fc1018a1f0	Product name	9	20250224
3082de91-569a-4d57-b379-acbf37f1d5c3	Product name	1	20210312
f76135bc-a210-42d9-851b-1b73cbaccdb3	Product name	1	20200511
423544b2-e325-49ee-8910-4c5dfe41906f	Product name	1	20181120
c9fd924b-0a8d-4d53-bf70-11070e24e4dd	Product name	2	20181120
ce1e7cc6-4850-4cb1-8dde-8010b2fbc359	Product name	1	20181120
eb454f54-2806-4c31-a08b-8dcb08261099	Product name	2	20181120
d9cebc09-c68d-46f5-bdcd-fd82e945cc27	Product name	1	20170705
16ba0c1e-2371-48a4-8b4c-a9a338dfe1f3	Product name	2	20160504
88514aea-9d58-4ed2-b135-9811fb14c8fb	Product name	1	20141209
0eba90a2-1cca-7e7b-28a5-85a09e2bc9a4	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16729-486-01	Methotrexate	100 in 1 BOTTLE	TABLET	100		8
16729-486-36	Methotrexate	36 in 1 BOTTLE	TABLET	36		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16729-486	METHOTREXATE TABLET [ACCORD HEALTHCARE INC.]	6	Current NDC, Legacy NDC, 2 package rows	20231203_874c7f43-a3be-4236-89cc-24c44e3c5813.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methotrexate	METHOTREXATE	Accord Healthcare Inc.	874c7f43-a3be-4236-89cc-24c44e3c5813	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213343 application number: ANDA213343 ndc (product): 16729-486
Methotrexate	METHOTREXATE	Bryant Ranch Prepack	4741a44f-0d0b-4380-84f6-231a8d1560fb	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213343 application number: ANDA213343
Methotrexate	METHOTREXATE	NuCare Pharmaceuticals, Inc.	50b2cfc7-dfe4-4406-e063-6294a90a2527	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213343 application number: ANDA213343
Methotrexate	METHOTREXATE	Coupler LLC	2f20d43e-a4b3-a839-e063-6394a90ace38	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213343 application number: ANDA213343
Methotrexate	METHOTREXATE	Proficient Rx LP	a76808f0-38a7-4b54-a4fb-3584f9058ae5	2024-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213343 application number: ANDA213343

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3IG1E710ZN	METHOTREXATE SODIUM	7413-34-5	METHOTREXATE SODIUM
YL5FZ2Y5U1	METHOTREXATE	59-05-2	Methotrexate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
105585	methotrexate 2.5 MG Oral Tablet	PSN	4741a44f-0d0b-4380-84f6-231a8d1560fb	105
105585	methotrexate 2.5 MG Oral Tablet	SCD	4741a44f-0d0b-4380-84f6-231a8d1560fb	105
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	4741a44f-0d0b-4380-84f6-231a8d1560fb	105
105585	methotrexate 2.5 MG Oral Tablet	PSN	874c7f43-a3be-4236-89cc-24c44e3c5813	8
105585	methotrexate 2.5 MG Oral Tablet	SCD	874c7f43-a3be-4236-89cc-24c44e3c5813	8
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	874c7f43-a3be-4236-89cc-24c44e3c5813	8
105585	methotrexate 2.5 MG Oral Tablet	PSN	2f20d43e-a4b3-a839-e063-6394a90ace38	1
105585	methotrexate 2.5 MG Oral Tablet	PSN	50b2cfc7-dfe4-4406-e063-6294a90a2527	1
105585	methotrexate 2.5 MG Oral Tablet	PSN	a76808f0-38a7-4b54-a4fb-3584f9058ae5	1
105585	methotrexate 2.5 MG Oral Tablet	SCD	2f20d43e-a4b3-a839-e063-6394a90ace38	1
105585	methotrexate 2.5 MG Oral Tablet	SCD	50b2cfc7-dfe4-4406-e063-6294a90a2527	1
105585	methotrexate 2.5 MG Oral Tablet	SCD	a76808f0-38a7-4b54-a4fb-3584f9058ae5	1
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	2f20d43e-a4b3-a839-e063-6394a90ace38	1
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	50b2cfc7-dfe4-4406-e063-6294a90a2527	1
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	a76808f0-38a7-4b54-a4fb-3584f9058ae5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16729-486-01	16729048601	100 TABLET in 1 BOTTLE (16729-486-01)	100 tablet	2020-08-24	0000-00-00	No	No	Current
16729-486-36	16729048636	36 in 1 BOTTLE						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methotrexate	Accord Healthcare Inc. \| Intas Pharmaceuticals Limited	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	8
Methotrexate	Bryant Ranch Prepack	2026-05-20	HUMAN PRESCRIPTION DRUG LABEL	105
Methotrexate	NuCare Pharmaceuticals, Inc.	2026-04-30	HUMAN PRESCRIPTION DRUG LABEL	1
Methotrexate	Coupler LLC	2025-02-27	HUMAN PRESCRIPTION DRUG LABEL	1
Methotrexate	Proficient Rx LP	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	1
Methotrexate	REMEDYREPACK INC.	2024-03-14	HUMAN PRESCRIPTION DRUG LABEL	9