Rasuvo

Product NDC: 59137-515
11-digit product format: 591370515
Labeler code: 59137
Product ID: 59137-515_29d04017-dd64-4dea-a064-7b3b0805f423
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methotrexate
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Medexus Pharma Inc.
Application: NDA205776
Marketing category: NDA
Marketing start: 2014-07-10
Substance: METHOTREXATE SODIUM
Active strength: 12.5 mg/.25mL
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 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N205776-001	RASUVO	METHOTREXATE	7.5MG/0.15ML (7.5MG/0.15ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10
N205776-002	RASUVO	METHOTREXATE	10MG/0.20ML (10MG/0.20ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10
N205776-003	RASUVO	METHOTREXATE	12.5MG/0.25ML (12.5MG/0.25ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10
N205776-004	RASUVO	METHOTREXATE	15MG/0.30ML (15MG/0.30ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10
N205776-005	RASUVO	METHOTREXATE	17.5MG/0.35ML (17.5MG/0.35ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10
N205776-006	RASUVO	METHOTREXATE	20MG/0.4ML (20MG/0.4ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10
N205776-007	RASUVO	METHOTREXATE	22.5MG/0.45ML (22.5MG/0.45ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10
N205776-008	RASUVO	METHOTREXATE	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10
N205776-009	RASUVO	METHOTREXATE	27.5MG/0.55ML (27.5MG/0.55ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	2014-07-10
N205776-010	RASUVO	METHOTREXATE	30MG/0.6ML (30MG/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N205776-001	8664231	2029-06-01	U-1442	2014-07-31
N205776-002	8664231	2029-06-01	U-1442	2014-07-31
N205776-003	8664231	2029-06-01	U-1442	2014-07-31
N205776-004	8664231	2029-06-01	U-1442	2014-07-31
N205776-005	8664231	2029-06-01	U-1442	2014-07-31
N205776-006	8664231	2029-06-01	U-1442	2014-07-31
N205776-007	8664231	2029-06-01	U-1442	2014-07-31
N205776-008	8664231	2029-06-01	U-1442	2014-07-31
N205776-009	8664231	2029-06-01	U-1442	2014-07-31
N205776-010	8664231	2029-06-01	U-1442	2014-07-31

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 11 · 420 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205776-001	RASUVO	7.5MG/0.15ML (7.5MG/0.15ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-002	RASUVO	10MG/0.20ML (10MG/0.20ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-003	RASUVO	12.5MG/0.25ML (12.5MG/0.25ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-004	RASUVO	15MG/0.30ML (15MG/0.30ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-005	RASUVO	17.5MG/0.35ML (17.5MG/0.35ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-006	RASUVO	20MG/0.4ML (20MG/0.4ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-007	RASUVO	22.5MG/0.45ML (22.5MG/0.45ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-008	RASUVO	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-009	RASUVO	27.5MG/0.55ML (27.5MG/0.55ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / SUBCUTANEOUS	RLD	2014-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-010	RASUVO	30MG/0.6ML (30MG/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205776-001	RASUVO	7.5MG/0.15ML (7.5MG/0.15ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-002	RASUVO	10MG/0.20ML (10MG/0.20ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-003	RASUVO	12.5MG/0.25ML (12.5MG/0.25ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-004	RASUVO	15MG/0.30ML (15MG/0.30ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-005	RASUVO	17.5MG/0.35ML (17.5MG/0.35ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-006	RASUVO	20MG/0.4ML (20MG/0.4ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-007	RASUVO	22.5MG/0.45ML (22.5MG/0.45ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-008	RASUVO	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-009	RASUVO	27.5MG/0.55ML (27.5MG/0.55ML)	SOLUTION / SUBCUTANEOUS	RLD	2014-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-010	RASUVO	30MG/0.6ML (30MG/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-001	RASUVO	7.5MG/0.15ML (7.5MG/0.15ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-002	RASUVO	10MG/0.20ML (10MG/0.20ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-003	RASUVO	12.5MG/0.25ML (12.5MG/0.25ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-004	RASUVO	15MG/0.30ML (15MG/0.30ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-005	RASUVO	17.5MG/0.35ML (17.5MG/0.35ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-006	RASUVO	20MG/0.4ML (20MG/0.4ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-007	RASUVO	22.5MG/0.45ML (22.5MG/0.45ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-008	RASUVO	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-009	RASUVO	27.5MG/0.55ML (27.5MG/0.55ML)	SOLUTION / SUBCUTANEOUS	RLD	2014-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-010	RASUVO	30MG/0.6ML (30MG/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205776-001	RASUVO	7.5MG/0.15ML (7.5MG/0.15ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-002	RASUVO	10MG/0.20ML (10MG/0.20ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-003	RASUVO	12.5MG/0.25ML (12.5MG/0.25ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-004	RASUVO	15MG/0.30ML (15MG/0.30ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-005	RASUVO	17.5MG/0.35ML (17.5MG/0.35ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-006	RASUVO	20MG/0.4ML (20MG/0.4ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-007	RASUVO	22.5MG/0.45ML (22.5MG/0.45ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-008	RASUVO	25MG/0.5ML (25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-009	RASUVO	27.5MG/0.55ML (27.5MG/0.55ML)	SOLUTION / SUBCUTANEOUS	RLD	2014-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-010	RASUVO	30MG/0.6ML (30MG/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2014-07-10	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 420 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N205776-001	8664231	2029-06-01	U-1442	2014-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-002	8664231	2029-06-01	U-1442	2014-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-003	8664231	2029-06-01	U-1442	2014-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-004	8664231	2029-06-01	U-1442	2014-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-005	8664231	2029-06-01	U-1442	2014-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-006	8664231	2029-06-01	U-1442	2014-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-007	8664231	2029-06-01	U-1442	2014-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-008	8664231	2029-06-01	U-1442	2014-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-009	8664231	2029-06-01	U-1442	2014-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205776-010	8664231	2029-06-01	U-1442	2014-07-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N205776-001	8664231	2029-06-01	U-1442	2014-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-002	8664231	2029-06-01	U-1442	2014-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-003	8664231	2029-06-01	U-1442	2014-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-004	8664231	2029-06-01	U-1442	2014-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-005	8664231	2029-06-01	U-1442	2014-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-006	8664231	2029-06-01	U-1442	2014-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-007	8664231	2029-06-01	U-1442	2014-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-008	8664231	2029-06-01	U-1442	2014-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-009	8664231	2029-06-01	U-1442	2014-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205776-010	8664231	2029-06-01	U-1442	2014-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-001	8664231	2029-06-01	U-1442	2014-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-002	8664231	2029-06-01	U-1442	2014-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-003	8664231	2029-06-01	U-1442	2014-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-004	8664231	2029-06-01	U-1442	2014-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-005	8664231	2029-06-01	U-1442	2014-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-006	8664231	2029-06-01	U-1442	2014-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-007	8664231	2029-06-01	U-1442	2014-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-008	8664231	2029-06-01	U-1442	2014-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-009	8664231	2029-06-01	U-1442	2014-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205776-010	8664231	2029-06-01	U-1442	2014-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205776-001	8664231	2029-06-01	U-1442	2014-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-002	8664231	2029-06-01	U-1442	2014-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-003	8664231	2029-06-01	U-1442	2014-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-004	8664231	2029-06-01	U-1442	2014-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-005	8664231	2029-06-01	U-1442	2014-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-006	8664231	2029-06-01	U-1442	2014-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-007	8664231	2029-06-01	U-1442	2014-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-008	8664231	2029-06-01	U-1442	2014-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-009	8664231	2029-06-01	U-1442	2014-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205776-010	8664231	2029-06-01	U-1442	2014-07-31	`6a471c1ec25d…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHOTREXATE SODIUM	12.5 mg/.25mL

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 · 18 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1441416	Internal RxNorm lookup
1544378	Internal RxNorm lookup
1544383	Internal RxNorm lookup
1544385	Internal RxNorm lookup
1544386	Internal RxNorm lookup
1544387	Internal RxNorm lookup
1544388	Internal RxNorm lookup
1544389	Internal RxNorm lookup
1544390	Internal RxNorm lookup
1544394	Internal RxNorm lookup
1544395	Internal RxNorm lookup
1544396	Internal RxNorm lookup
1544397	Internal RxNorm lookup
1544398	Internal RxNorm lookup
1544401	Internal RxNorm lookup
1544402	Internal RxNorm lookup
1544403	Internal RxNorm lookup
1544404	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
d0075461-0e7e-4967-9c9b-d6440e912c0e	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	SPL version
59137-515-00	Rasuvo	0.25 mL in 1 PACKAGE	INJECTION, SOLUTION	0.25	10
59137-515-01	Rasuvo	1 in 1 CARTON	INJECTION, SOLUTION	1	10
59137-515-04	Rasuvo	4 in 1 CARTON	INJECTION, SOLUTION	4	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59137-515-00	ML - Milliliter	59137-515	5be4ca2f-b1a1-45c6-b3eb-0e368162d2e8	1	2017-03-06
59137-515-01	ML - Milliliter	59137-515	770e9f96-83e6-4a50-828c-5ea7a4b5dce4	1	2014-09-03
59137-515-04	ML - Milliliter	59137-515	4506f4a4-6a31-453f-ab33-2a8a1d96d1bc	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
methotrexate sodium	ACTIVE INGREDIENT	3IG1E710ZN	RASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]	3
methotrexate	ACTIVE MOIETY	YL5FZ2Y5U1	RASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]	3
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	RASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]	3
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	RASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]	3
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	RASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]	3
water	INACTIVE INGREDIENT	059QF0KO0R	RASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDAC PHARMA, INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59137-515	RASUVO (METHOTREXATE) INJECTION, SOLUTION [MEDEXUS PHARMA INC.]	9	Current NDC, Legacy NDC, 3 package rows	20241211_d0075461-0e7e-4967-9c9b-d6440e912c0e.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rasuvo	METHOTREXATE	Medexus Pharma Inc.	d0075461-0e7e-4967-9c9b-d6440e912c0e	2025-12-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 205776 application number: NDA205776 ndc (product): 59137-515

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
1544378	methotrexate 10 MG in 0.2 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544385	methotrexate 12.5 MG in 0.25 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544387	methotrexate 15 MG in 0.3 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544389	methotrexate 17.5 MG in 0.35 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1441416	methotrexate 20 MG in 0.4 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544395	methotrexate 22.5 MG in 0.45 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544397	methotrexate 25 MG in 0.5 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544401	methotrexate 30 MG in 0.6 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544403	methotrexate 7.5 MG in 0.15 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544383	Rasuvo 10 MG in 0.2 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544386	Rasuvo 12.5 MG in 0.25 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544388	Rasuvo 15 MG in 0.3 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544390	Rasuvo 17.5 MG in 0.35 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544394	Rasuvo 20 MG in 0.4 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544396	Rasuvo 22.5 MG in 0.45 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544398	Rasuvo 25 MG in 0.5 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544402	Rasuvo 30 MG in 0.6 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544404	Rasuvo 7.5 MG in 0.15 ML Auto-Injector	PSN	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544404	0.15 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]	SBD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544383	0.2 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]	SBD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544386	0.25 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]	SBD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544388	0.3 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]	SBD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544390	0.35 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]	SBD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544394	0.4 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]	SBD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544396	0.45 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]	SBD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544398	0.5 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]	SBD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544402	0.6 ML methotrexate 50 MG/ML Auto-Injector [Rasuvo]	SBD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544403	0.15 ML methotrexate 50 MG/ML Auto-Injector	SCD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544378	0.2 ML methotrexate 50 MG/ML Auto-Injector	SCD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544385	0.25 ML methotrexate 50 MG/ML Auto-Injector	SCD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544387	0.3 ML methotrexate 50 MG/ML Auto-Injector	SCD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544389	0.35 ML methotrexate 50 MG/ML Auto-Injector	SCD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1441416	0.4 ML methotrexate 50 MG/ML Auto-Injector	SCD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544395	0.45 ML methotrexate 50 MG/ML Auto-Injector	SCD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544397	0.5 ML methotrexate 50 MG/ML Auto-Injector	SCD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544401	0.6 ML methotrexate 50 MG/ML Auto-Injector	SCD	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544404	0.15 ML Rasuvo 50 MG/ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544383	0.2 ML Rasuvo 50 MG/ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544386	0.25 ML Rasuvo 50 MG/ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544388	0.3 ML Rasuvo 50 MG/ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544390	0.35 ML Rasuvo 50 MG/ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544394	0.4 ML Rasuvo 50 MG/ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544396	0.45 ML Rasuvo 50 MG/ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544398	0.5 ML Rasuvo 50 MG/ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544402	0.6 ML Rasuvo 50 MG/ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544378	methotrexate (as methotrexate sodium) 10 MG per 0.2 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544385	methotrexate (as methotrexate sodium) 12.5 MG per 0.25 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544387	methotrexate (as methotrexate sodium) 15 MG per 0.3 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544389	methotrexate (as methotrexate sodium) 17.5 MG per 0.35 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1441416	methotrexate (as methotrexate sodium) 50 MG/ML 0.4 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544395	methotrexate (as methotrexate sodium) 50 MG/ML in 0.45 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544397	methotrexate (as methotrexate sodium) 50 MG/ML in 0.5 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544401	methotrexate (as methotrexate sodium) 50 MG/ML in 0.6 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544403	methotrexate (as methotrexate sodium) 7.5 MG per 0.15 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544378	methotrexate 10 MG per 0.2 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544385	methotrexate 12.5 MG per 0.25 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544387	methotrexate 15 MG per 0.3 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544389	methotrexate 17.5 MG per 0.35 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1441416	methotrexate 20 MG per 0.4 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544395	methotrexate 22.5 MG per 0.45 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544397	methotrexate 25 MG per 0.5 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544401	methotrexate 30 MG per 0.6 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544403	methotrexate 7.5 MG per 0.15 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544404	Rasuvo (as methotrexate sodium) 50 MG/ML in 0.15 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544383	Rasuvo (as methotrexate sodium) 50 MG/ML in 0.2 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544386	Rasuvo (as methotrexate sodium) 50 MG/ML in 0.25 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544388	Rasuvo (as methotrexate sodium) 50 MG/ML in 0.3 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544390	Rasuvo (as methotrexate sodium) 50 MG/ML in 0.35 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544394	Rasuvo (as methotrexate sodium) 50 MG/ML in 0.4 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544396	Rasuvo (as methotrexate sodium) 50 MG/ML in 0.45 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544398	Rasuvo (as methotrexate sodium) 50 MG/ML in 0.5 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544402	Rasuvo (as methotrexate sodium) 50 MG/ML in 0.6 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544383	Rasuvo 10 MG per 0.2 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544386	Rasuvo 12.5 MG per 0.25 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544388	Rasuvo 15 MG per 0.3 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544390	Rasuvo 17.5 MG per 0.35 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544394	Rasuvo 20 MG per 0.4 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544396	Rasuvo 22.5 MG per 0.45 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544398	Rasuvo 25 MG per 0.5 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10
1544402	Rasuvo 30 MG per 0.6 ML Auto-Injector	SY	d0075461-0e7e-4967-9c9b-d6440e912c0e	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59137-515-00	59137051500	0.25 mL in 1 PACKAGE	0.25 ml					Historical
59137-515-01	59137051501	1 PACKAGE in 1 CARTON (59137-515-01) / .25 mL in 1 PACKAGE (59137-515-00)	1 package	2014-07-10	0000-00-00	No	No	Current
59137-515-04	59137051504	4 PACKAGE in 1 CARTON (59137-515-04) / .25 mL in 1 PACKAGE (59137-515-00)	4 package	2014-07-10	0000-00-00	No	No	Current