Pemetrexed

Product NDC: 16729-522
11-digit product format: 167290522
Labeler code: 16729
Product ID: 16729-522_e85650c8-383d-add2-e053-2a95a90a1f71
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pemetrexed disodium
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Accord Healthcare Inc.
Application: NDA214408
Marketing category: NDA
Marketing start: 2022-09-08
Marketing end: 0000-00-00
Substance: PEMETREXED DISODIUM HEMIPENTAHYDRATE
Active strength: 25 mg/mL
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	16729-522		D	Discontinued by firm	2026-08-17
excluded package	package	16729-522	16729-522-05	D	Discontinued by firm	2026-08-17
excluded package	package	16729-522	16729-522-28	D	Discontinued by firm	2026-08-17
excluded package	package	16729-522	16729-522-35	D	Discontinued by firm	2026-08-17
excluded package	package	16729-522	16729-522-64	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16729-522-64	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16729-522-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16729-522-35	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16729-522-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16729-522-64	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16729-522-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16729-522-35	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16729-522-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16729-522-64	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16729-522-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16729-522-35	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16729-522-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16729-522-64	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16729-522-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16729-522-35	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16729-522-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16729-522-64	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16729-522-28	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16729-522-35	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16729-522-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16729-522-64	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16729-522-28	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16729-522-35	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16729-522-05	`cdf11ea48f46…`	`ba0047e9e063…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N214408-001	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19
N214408-002	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19
N214408-003	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19
N214408-004	PEMETREXED DISODIUM	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19

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 3 · 112 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	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD	2022-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214408-001	PEMETREXED DISODIUM	EQ 100MG BASE/4ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214408-002	PEMETREXED DISODIUM	EQ 500MG BASE/20ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214408-003	PEMETREXED DISODIUM	EQ 850MG BASE/34ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214408-004	PEMETREXED DISODIUM	EQ 1GM BASE/40ML (EQ 25MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2022-07-19	`d8e5a09893c0…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16729-522-05	ML - Milliliter	16729-522	54a500d8-11e4-4f10-a3a0-d394c47c9547	1	2022-08-04
16729-522-28	ML - Milliliter	16729-522	6313bb64-d6f4-4216-baa1-fbca080bb7cd	1	2022-08-04
16729-522-35	ML - Milliliter	16729-522	0a1eb1b5-f35b-4a72-ad2e-510bbbe3e8ea	1	2022-08-04
16729-522-64	ML - Milliliter	16729-522	50aa8013-d744-41c4-b4e5-15a40ca216d6	1	2022-08-04

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
16729-522-05	16729052205	1 VIAL in 1 CARTON (16729-522-05) > 20 mL in 1 VIAL	1 vial	2022-08-26	0000-00-00	No	No	Current
16729-522-28	16729052228	1 VIAL in 1 CARTON (16729-522-28) > 34 mL in 1 VIAL	1 vial	2022-08-26	0000-00-00	No	No	Current
16729-522-35	16729052235	1 VIAL in 1 CARTON (16729-522-35) > 40 mL in 1 VIAL	1 vial	2022-08-26	0000-00-00	No	No	Current
16729-522-64	16729052264	1 VIAL in 1 CARTON (16729-522-64) > 4 mL in 1 VIAL	1 vial	2022-08-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pemetrexed	Accord Healthcare Inc. \| Intas Pharmaceuticals Ltd	2025-02-06	HUMAN PRESCRIPTION DRUG LABEL	5