Pemetrexed

Product NDC: 50742-341
11-digit product format: 507420341
Labeler code: 50742
Product ID: 50742-341_12d4ace5-4ce2-469a-9a42-380a68328670
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pemetrexed disodium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA204890
Marketing category: ANDA
Marketing start: 2022-05-24
Marketing end: 0000-00-00
Substance: PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength: 500 mg/20mL
Pharmacologic classes: Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	50742-341		D	Discontinued by firm		2026-08-17
excluded package	package	50742-341	50742-341-01	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204890-001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25
A204890-002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP		2022-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204890-001	AP
A204890-002	AP

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 · 60 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	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204890-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204890-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-05-25	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	A204890-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204890-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204890-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204890-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204890-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204890-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204890-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204890-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204890-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204890-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204890-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204890-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204890-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204890-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204890-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204890-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204890-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204890-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204890-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204890-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204890-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204890-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204890-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204890-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204890-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204890-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204890-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204890-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204890-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204890-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204890-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204890-002	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204890-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204890-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204890-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204890-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204890-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204890-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204890-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204890-002	AP	1	`a72a2bbeb626…`

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
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
a620f3f0-1e13-41d6-a838-d5407971d39e	Product name	1	20230313
8766e415-735a-4d2c-b173-894ecced3fd9	Product name	1	20230308
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-341-01	EA - Each	50742-341	44e3306b-794e-429c-bf82-f87a191ec358	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-341	PEMETREXED (PEMETREXED DISODIUM) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [INGENUS PHARMACEUTICALS, LLC]	3	Legacy NDC	20231229_0346155f-a455-4044-8d5f-eacb97a8c8f0.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pemetrexed	PEMETREXED DISODIUM	Sagent Pharmaceuticals	fa8f1f52-3f05-4ae8-bfec-7f0a029e6825	2024-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204890 application number: ANDA204890
Pemetrexed	PEMETREXED DISODIUM	BluePoint Laboratories	c9f34c00-1176-4f44-8cff-bae5bdc0c40f	2022-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204890 application number: ANDA204890
Pemetrexed	PEMETREXED DISODIUM	Qilu Pharmaceutical Co., Ltd.	46a9b89d-7135-4e0c-b8e4-52580554769b	2021-08-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204890 application number: ANDA204890

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-341-01	50742034101	1 VIAL in 1 CARTON (50742-341-01) > 20 mL in 1 VIAL	1 vial	2022-05-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pemetrexed	Ingenus Pharmaceuticals, LLC \| Qilu Pharmaceutical (Hainan) Co., Ltd.	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	4