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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
METHOTREXATE SODIUM	2.5 mg/1

Field, Values table
Field	Values
Unii	3IG1E710ZN
Rxcui	105585

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2eb9a854-4fbc-9bbe-3199-41fc1018a1f0	Product name	9	20250224
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

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

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0555-0572-02	EA - Each	0555-0572	9e233575-6d9d-4d5c-a6d9-60adb8bc12f4	1	2012-07-24
0555-0572-35	EA - Each	0555-0572	f0623f90-9c02-478d-b127-f5b41d2a0749	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHOTREXATE SODIUM	ACTIVE INGREDIENT	3IG1E710ZN	METHOTREXATE TABLET [BARR LABORATORIES INC.]	4
METHOTREXATE	ACTIVE MOIETY	YL5FZ2Y5U1	METHOTREXATE TABLET [BARR LABORATORIES INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	METHOTREXATE TABLET [BARR LABORATORIES INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHOTREXATE TABLET [BARR LABORATORIES INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	METHOTREXATE TABLET [BARR LABORATORIES INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHOTREXATE TABLET [BARR LABORATORIES INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	METHOTREXATE TABLET [BARR LABORATORIES INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	METHOTREXATE TABLET [BARR LABORATORIES INC.]	4
SODIUM CARBONATE MONOHYDRATE	INACTIVE INGREDIENT	2A1Q1Q3557	METHOTREXATE TABLET [BARR LABORATORIES INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHOTREXATE TABLET [BARR LABORATORIES INC.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METHOTREXATE TABLET [BARR LABORATORIES INC.]	4

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

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
105585	methotrexate 2.5 MG Oral Tablet	PSN	9b34b1d8-d125-41a2-9f6f-3fab67b573bd	16
105585	methotrexate 2.5 MG Oral Tablet	SCD	9b34b1d8-d125-41a2-9f6f-3fab67b573bd	16
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	9b34b1d8-d125-41a2-9f6f-3fab67b573bd	16
105585	methotrexate 2.5 MG Oral Tablet	PSN	22e10810-16fb-4c84-bccf-972405b77ef8	15
105585	methotrexate 2.5 MG Oral Tablet	SCD	22e10810-16fb-4c84-bccf-972405b77ef8	15
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	22e10810-16fb-4c84-bccf-972405b77ef8	15
105585	methotrexate 2.5 MG Oral Tablet	PSN	e6611304-4622-4b2e-9b94-57fbad023ae2	9
105585	methotrexate 2.5 MG Oral Tablet	SCD	e6611304-4622-4b2e-9b94-57fbad023ae2	9
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	e6611304-4622-4b2e-9b94-57fbad023ae2	9
105585	methotrexate 2.5 MG Oral Tablet	PSN	02862eb3-5508-4ea9-99fb-262551b6beeb	7
105585	methotrexate 2.5 MG Oral Tablet	SCD	02862eb3-5508-4ea9-99fb-262551b6beeb	7
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	02862eb3-5508-4ea9-99fb-262551b6beeb	7

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methotrexate	Teva Pharmaceuticals USA, Inc.	2026-05-07	HUMAN PRESCRIPTION DRUG LABEL	16
Methotrexate	A-S Medication Solutions	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	15
Methotrexate	Bryant Ranch Prepack	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	9
Methotrexate Tablets USP	A-S Medication Solutions	2018-08-23	HUMAN PRESCRIPTION DRUG LABEL	7