Pemetrexed disodium

Product NDC: 70121-1233
11-digit product format: 701211233
Labeler code: 70121
Product ID: 70121-1233_d7475c11-64bf-4c22-85ba-704e874bde69
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pemetrexed
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA210047
Marketing category: ANDA
Marketing start: 2022-08-10
Marketing end: 0000-00-00
Substance: PEMETREXED DISODIUM
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	70121-1233		D	Discontinued by firm		2026-08-17
excluded package	package	70121-1233	70121-1233-1	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
A210047-001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS			2022-08-04
A210047-002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS			2023-05-08

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 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210047-001	PEMETREXED DISODIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	2022-08-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210047-002	PEMETREXED DISODIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	2023-05-08	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210047-001	AP	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210047-002	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210047-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210047-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210047-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210047-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210047-001	AP	1	`e64feba35796…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70121-1233	PEMETREXED DISODIUM (PEMETREXED) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMNEAL PHARMACEUTICALS LLC]	10	Legacy NDC	20230517_e4a92d35-a0ac-486e-94a7-289ede47af46.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2PKU919BA9	PEMETREXED DISODIUM	150399-23-8	PEMETREXED DISODIUM
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
70121-1233-1	70121123301	1 VIAL, SINGLE-DOSE in 1 CARTON (70121-1233-1) > 20 mL in 1 VIAL, SINGLE-DOSE	2022-08-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pemetrexed disodium	Amneal Pharmaceuticals LLC \| Amneal Oncology Private Limited	2022-11-11	HUMAN PRESCRIPTION DRUG LABEL	10