PEMETREXED

Product NDC: 0338-0720
Requested package NDC: 0338-0720-01
11-digit product format: 003380720
Labeler code: 0338
Product ID: 0338-0720_94c2f5f8-332c-4552-9919-0ae23b014788
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PEMETREXED
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: ANDA214436
Marketing category: ANDA
Marketing start: 2022-08-18
Marketing end: 0000-00-00
Substance: PEMETREXED DISODIUM HEPTAHYDRATE
Active strength: 100 mg/10mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0338-0720	0338-0720-01	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
A214436-001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS			2022-08-18
A214436-002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS			2022-08-18

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 · 56 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	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS		2022-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS		2022-08-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS		2022-08-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS		2022-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS		2022-08-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS		2022-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS		2022-08-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS		2022-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214436-001	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214436-002	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	AP	2022-08-18	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214436-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214436-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214436-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214436-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214436-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214436-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214436-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214436-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214436-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214436-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214436-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214436-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214436-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214436-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214436-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214436-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214436-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214436-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214436-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214436-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214436-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214436-002	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214436-001	AP	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214436-002	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214436-001	AP	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214436-002	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214436-001	AP	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214436-002	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214436-001	AP	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214436-002	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214436-001	AP	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214436-002	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214436-001	AP	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214436-002	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214436-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214436-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214436-001	AP	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A214436-002	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214436-001	AP	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A214436-002	AP	1	`3bdfa0b2c4d7…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-0720-01	EA - Each	0338-0720	285b99f5-f1ab-4d80-81d9-c83e530035d4	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-0720	PEMETREXED INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE COMPANY]	6	Legacy NDC	20250519_9a93c625-ae03-4aa7-8603-45a335210080.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9T47E4OM16	PEMETREXED DISODIUM HEPTAHYDRATE	357166-29-1	PEMETREXED DISODIUM HEPTAHYDRATE
04Q9AIZ7NO	PEMETREXED	137281-23-3	PEMETREXED

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0338-0720-01	00338072001	1 VIAL, SINGLE-DOSE in 1 CARTON (0338-0720-01) > 10 mL in 1 VIAL, SINGLE-DOSE	2022-08-18	0000-00-00	No	No	Current