PEMETREXED DIPOTASSIUM

Product NDC: 83831-112
Requested package NDC: 83831-112-01
11-digit product format: 838310112
Labeler code: 83831
Product ID: 83831-112_0c1baa15-83bb-45a0-a3ab-855a4fee9129
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pemetrexed dipotassium
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Avyxa Pharma, LLC
Application: NDA210661
Marketing category: NDA
Marketing start: 2025-01-01
Substance: PEMETREXED
Active strength: 500 mg/20mL
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

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	83831-112	83831-112-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	83831-112	83831-112-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	83831-112	83831-112-01	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
N210661-001	AXTLE	PEMETREXED DIPOTASSIUM	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-28
N210661-002	AXTLE	PEMETREXED DIPOTASSIUM	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS		RLD, RS	2024-06-28

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.

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	N210661-001	AXTLE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210661-002	AXTLE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210661-001	AXTLE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210661-002	AXTLE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210661-001	AXTLE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210661-002	AXTLE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210661-001	AXTLE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210661-002	AXTLE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210661-001	AXTLE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210661-002	AXTLE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210661-001	AXTLE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210661-002	AXTLE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210661-001	AXTLE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210661-002	AXTLE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210661-001	PEMETREXED	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210661-002	PEMETREXED	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210661-001	PEMETREXED	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210661-002	PEMETREXED	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210661-001	PEMETREXED	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210661-002	PEMETREXED	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210661-001	PEMETREXED	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210661-002	PEMETREXED	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210661-001	PEMETREXED	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210661-002	PEMETREXED	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210661-001	PEMETREXED	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210661-002	PEMETREXED	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210661-001	AXTLE	EQ 100MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210661-002	AXTLE	EQ 500MG BASE/VIAL	POWDER / INTRAVENOUS	RLD, RS	2024-06-28	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: PEMETREXED DIPOTASSIUM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PEMETREXED	500 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04Q9AIZ7NO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1728072	Internal RxNorm lookup
1728077	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
adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc	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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83831-112-01	PEMETREXED DIPOTASSIUM	20 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	20		6
83831-112-01	PEMETREXED DIPOTASSIUM	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
83831-112-01	EA - Each	83831-112	35961074-36b5-4952-b8d4-e61b3aae6878	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83831-112	PEMETREXED DIPOTASSIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVYXA PHARMA, LLC]	6	Current NDC, 2 package rows	20250207_adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc.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
AXTLE	PEMETREXED	Avyxa Pharma, LLC	9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210661 application number: NDA210661
PEMETREXED DIPOTASSIUM	PEMETREXED DIPOTASSIUM	Avyxa Pharma, LLC	adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc	2025-02-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210661 application number: NDA210661 ndc (package): 83831-112-01 ndc (product): 83831-112 ndc11 (package): 83831011201

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04Q9AIZ7NO	PEMETREXED	137281-23-3	PEMETREXED

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1728077	PEMEtrexed 100 MG Injection	PSN	adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc	6
1728072	PEMEtrexed 500 MG Injection	PSN	adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc	6
1728077	pemetrexed 100 MG Injection	SCD	adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc	6
1728072	pemetrexed 500 MG Injection	SCD	adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc	6
1728077	pemetrexed 100 MG Injection	SY	adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc	6
1728072	pemetrexed 500 MG Injection	SY	adc9ce4c-926a-4ee8-bd0d-d06fc89c17fc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83831-112-01	83831011201	1 VIAL in 1 CARTON (83831-112-01) / 20 mL in 1 VIAL	1 vial	2025-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PEMETREXED DIPOTASSIUM	Avyxa Pharma, LLC \| Avyxa Holdings, LLC. \| Gland Pharma Limited	2025-02-05	HUMAN PRESCRIPTION DRUG LABEL	6