Methotrexate

Product NDC: 43063-439
11-digit product format: 430630439
Labeler code: 43063
Product ID: 43063-439_a8d630fd-e0d7-2b19-e053-2995a90aa8c8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methotrexate
Dosage form: TABLET
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA081099
Marketing category: ANDA
Marketing start: 1990-11-01
Marketing end: 0000-00-00
Substance: METHOTREXATE SODIUM
Active strength: 3 mg/1
Pharmacologic classes: Folate Analog Metabolic Inhibitor [EPC],Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	43063-439		D	Discontinued by firm		2026-08-17
excluded package	package	43063-439	43063-439-30	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43063-439-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43063-439-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43063-439-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43063-439-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43063-439-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43063-439-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43063-439-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43063-439-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43063-439-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43063-439-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43063-439-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43063-439-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A081099-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A081099-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A081099-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A081099-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A081099-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A081099-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A081099-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A081099-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A081099-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A081099-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A081099-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A081099-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A081099-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A081099-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A081099-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A081099-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A081099-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A081099-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A081099-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A081099-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A081099-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A081099-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A081099-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A081099-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A081099-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A081099-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A081099-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A081099-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A081099-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A081099-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A081099-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A081099-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A081099-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A081099-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A081099-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A081099-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A081099-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A081099-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A081099-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A081099-001	AB	1	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-439-30	EA - Each	43063-439	ed2afdfb-61b6-499e-b00b-535d35a03e54	1	2013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHOTREXATE SODIUM	ACTIVE INGREDIENT	3IG1E710ZN	METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.]	4
METHOTREXATE	ACTIVE MOIETY	YL5FZ2Y5U1	METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, 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
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METHOTREXATE TABLET [PD-RX PHARMACEUTICALS, INC.]	4

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
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-439-30	43063043930	30 TABLET in 1 BOTTLE, PLASTIC (43063-439-30)	30 tablet	2012-08-22	0000-00-00	No	No	Current