Methotrexate

Product NDC: 47335-235
11-digit product format: 473350235
Labeler code: 47335
Product ID: 47335-235_aca00bb2-33db-4471-b932-8690641f48fd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methotrexate Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA201749
Marketing category: ANDA
Marketing start: 2017-11-10
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: 2027-12-31
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
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
47335-235-83	Methotrexate	100 in 1 BOTTLE	TABLET	100		9
47335-235-96	Methotrexate	36 in 1 BOTTLE	TABLET	36		9

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47335-235-83	EA - Each	47335-235	cbed6fcc-6767-4bde-b341-c515fa04d055	1	2018-01-12
47335-235-96	EA - Each	47335-235	95937d6a-5b19-445d-8177-736c9d31afea	1	2018-01-12

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47335-235	METHOTREXATE (METHOTREXATE SODIUM) TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20210924_8f1260de-b60c-4f0e-8af6-0e957b0a281b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3IG1E710ZN	METHOTREXATE SODIUM	7413-34-5	METHOTREXATE SODIUM

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
105585	methotrexate 2.5 MG Oral Tablet	PSN	c7592288-ac24-46c6-8cec-9abe23d7e81e	100
105585	methotrexate 2.5 MG Oral Tablet	SCD	c7592288-ac24-46c6-8cec-9abe23d7e81e	100
105585	methotrexate 2.5 MG (as methotrexate sodium) Oral Tablet	SY	c7592288-ac24-46c6-8cec-9abe23d7e81e	100

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47335-235-83	47335023583	100 TABLET in 1 BOTTLE (47335-235-83)	100 tablet	2017-11-10	0000-00-00	No	No	Current
47335-235-96	47335023596	36 TABLET in 1 BOTTLE (47335-235-96)	36 tablet	2017-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methotrexate	Sun Pharmaceutical Industries, Inc. \| Orion Corporation, Orion Pharma \| Orion Corporation ORION PHARMA	2026-05-21	HUMAN PRESCRIPTION DRUG LABEL	10
Methotrexate	Bryant Ranch Prepack	2023-12-07	HUMAN PRESCRIPTION DRUG LABEL	100