Home NDC 83831-132 AXTLE
Product NDC 83831-132
11-digit product format 838310132
Labeler code 83831
Product ID 83831-132_6e125601-ebbb-4fe6-9d9e-80d093b12532
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name pemetrexed
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 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 AXTLE
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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1728072 Internal RxNorm lookup 1728077 Internal RxNorm lookup 2699339 Internal RxNorm lookup 2699341 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 83831-132-01 AXTLE 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 9 83831-132-01 AXTLE 20 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 20 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83831-132 AXTLE (PEMETREXED) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AVYXA PHARMA, LLC] 2 Current NDC, 2 package rows 20250108_9582c46c-d8b0-44b7-a2ee-9c86f5e9b7b1.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 83831-132-01 83831013201 1 VIAL in 1 CARTON (83831-132-01) / 20 mL in 1 VIAL 1 vial 2025-01-01 No No Current