Home NDC 83831-112 PEMETREXED DIPOTASSIUM
Product NDC 83831-112
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 · 6 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 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 83831-112-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 83831-112-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 83831-112-01 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 Product TE source text 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.
DailyMed Product Concepts# 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 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.
DailyMed RxNorm Mappings# 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