PEMRYDI RTU

Product NDC: 70121-2462
11-digit product format: 701212462
Labeler code: 70121
Product ID: 70121-2462_b6a00be1-95d1-4b91-93bf-4430a57eeff6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pemetrexed disodium
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Amneal Pharmaceuticals LLC
Application: NDA215179
Marketing category: NDA
Marketing start: 2023-06-06
Substance: PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength: 1000 mg/100mL
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215179-001	PEMETREXED	PEMETREXED DISODIUM	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22
N215179-002	PEMETREXED	PEMETREXED DISODIUM	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22
N215179-003	PEMETREXED	PEMETREXED DISODIUM	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N215179-001	11147817	2035-03-26	Drug product	2023-06-06
N215179-002	11147817	2035-03-26	Drug product	2023-06-06
N215179-003	11147817	2035-03-26	Drug product	2023-06-06

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 · 69 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	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215179-002	PEMETREXED	EQ 500MG/50ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215179-003	PEMETREXED	EQ 1GM/100ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215179-001	PEMETREXED	EQ 100MG/10ML BASE (10MG/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-05-22	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 69 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215179-002	11147817	2035-03-26	Drug product	2023-06-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215179-003	11147817	2035-03-26	Drug product	2023-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215179-001	11147817	2035-03-26	Drug product	2023-06-06	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PEMETREXED DISODIUM HEMIPENTAHYDRATE	1000 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F4GSH45R4C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2637958	Internal RxNorm lookup
2637964	Internal RxNorm lookup
2637966	Internal RxNorm lookup
2637967	Internal RxNorm lookup
2637968	Internal RxNorm lookup
2637969	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
0f006b06-ab85-423d-ba0c-dfc3fc25844e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6b7ab8f1-bb38-4c30-8b8b-003c0fe639ea	Product name	1	20250303
0976ea44-ea26-403d-a39d-71fffc6a3d33	Product name	4	20250225
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
f15e8921-7cd5-4c00-9cde-9fa0c9eaca68	Product name	1	20231013
0bb393b5-af67-4798-84a7-b797956b02a5	Product name	1	20230830
7ea5dc07-b4d4-439d-8145-a10a534148e7	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
a620f3f0-1e13-41d6-a838-d5407971d39e	Product name	1	20230313
8766e415-735a-4d2c-b173-894ecced3fd9	Product name	1	20230308
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
2e254488-9fcb-41b3-a7c3-e2c9a3941b29	Product name	1	20200603
b4ff0805-126a-406d-9cae-fc34fd8e8889	Product name	1	20190711
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70121-2462-1	PEMRYDI RTU	1 in 1 CARTON	INJECTION	1		8
70121-2462-1	PEMRYDI RTU	100 mL in 1 VIAL	INJECTION	100		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70121-2462	PEMRYDI RTU (PEMETREXED DISODIUM) INJECTION [AMNEAL PHARMACEUTICALS LLC]	7	Current NDC, 2 package rows	20241212_0f006b06-ab85-423d-ba0c-dfc3fc25844e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PEMRYDI RTU	PEMETREXED DISODIUM	Amneal Pharmaceuticals LLC	0f006b06-ab85-423d-ba0c-dfc3fc25844e	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215179 application number: NDA215179 ndc (product): 70121-2462
Pemetrexed	PEMETREXED DISODIUM	Shilpa Medicare Limited	fe432994-e61b-4a87-8c98-cc20b847d0fe	2024-11-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215179 application number: NDA215179

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F4GSH45R4C	PEMETREXED DISODIUM HEMIPENTAHYDRATE	357166-30-4	PEMETREXED DISODIUM HEMIPENTAHYDRATE
2PKU919BA9	PEMETREXED DISODIUM	150399-23-8	Pemetrexed disodium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2637958	PEMEtrexed 100 MG in 10 ML Injection	PSN	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637966	PEMEtrexed 1000 MG in 100 ML Injection	PSN	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637968	PEMEtrexed 500 MG in 50 ML Injection	PSN	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637964	PEMRYDI RTU 100 MG in 10 ML Injection	PSN	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637967	PEMRYDI RTU 1000 MG in 100 ML Injection	PSN	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637969	PEMRYDI RTU 500 MG in 50 ML Injection	PSN	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637964	10 ML pemetrexed 10 MG/ML Injection [Pemrydi Rtu]	SBD	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637967	100 ML pemetrexed 10 MG/ML Injection [Pemrydi Rtu]	SBD	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637969	50 ML pemetrexed 10 MG/ML Injection [Pemrydi Rtu]	SBD	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637958	10 ML pemetrexed 10 MG/ML Injection	SCD	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637966	100 ML pemetrexed 10 MG/ML Injection	SCD	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637968	50 ML pemetrexed 10 MG/ML Injection	SCD	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637958	pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 10 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637966	pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 100 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637968	pemetrexed (as disodium hemipentahydrate) 10 MG/ML per 50 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637958	pemetrexed (as disodium hemipentahydrate) 100 MG per 10 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637966	pemetrexed (as disodium hemipentahydrate) 1000 MG per 100 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637968	pemetrexed (as disodium hemipentahydrate) 500 MG per 50 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637964	Pemrydi Rtu 10 MG/ML per 10 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637967	Pemrydi Rtu 10 MG/ML per 100 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637969	Pemrydi Rtu 10 MG/ML per 50 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637964	Pemrydi Rtu 100 MG per 10 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637967	Pemrydi Rtu 1000 MG per 100 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8
2637969	Pemrydi Rtu 500 MG per 50 ML Injection	SY	0f006b06-ab85-423d-ba0c-dfc3fc25844e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70121-2462-1	70121246201	1 VIAL in 1 CARTON (70121-2462-1) / 100 mL in 1 VIAL	1 vial	2023-06-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PEMRYDI RTU	Amneal Pharmaceuticals LLC \| Zydus Lifesciences Limited	2025-07-08	HUMAN PRESCRIPTION DRUG LABEL	8