Home NDC 52652-2001 Xatmep
Product NDC 52652-2001
11-digit product format 526522001
Labeler code 52652
Product ID 52652-2001_461e9d94-1451-904d-e063-6294a90a05f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methotrexate
Dosage form SOLUTION
Route ORAL
Labeler Azurity Pharmaceuticals, Inc.
Application NDA208400
Marketing category NDA
Marketing start 2017-05-01
Substance METHOTREXATE
Active strength 2.5 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208400-001 XATMEP METHOTREXATE SODIUM EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25
Orange Book patents# Current patent rows page 1 of 1 · 9 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208400-001 10231927 2033-01-02 U-1349 2019-04-01 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 N208400-001 11969503 2033-01-02 Drug product 2024-05-15 N208400-001 12396947 2033-01-02 Drug product 2025-09-15 N208400-001 9259427 2033-01-02 Drug product 2017-05-12 N208400-001 9855215 2033-01-02 Drug product 2018-01-19
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 2 · 42 observed 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 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208400-001 XATMEP EQ 2MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208400-001 XATMEP EQ 2MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208400-001 XATMEP EQ 2MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208400-001 XATMEP EQ 2MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N208400-001 XATMEP EQ 2.5MG BASE/ML SOLUTION / ORAL RLD, RS 2017-04-25 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 8 · 293 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 10231927 2033-01-02 U-1349 2019-04-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 11969503 2033-01-02 Drug product 2024-05-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 12396947 2033-01-02 Drug product 2025-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 9259427 2033-01-02 Drug product 2017-05-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208400-001 9855215 2033-01-02 Drug product 2018-01-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 10231927 2033-01-02 U-1349 2019-04-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 11969503 2033-01-02 Drug product 2024-05-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 12396947 2033-01-02 Drug product 2025-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 9259427 2033-01-02 Drug product 2017-05-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208400-001 9855215 2033-01-02 Drug product 2018-01-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 10231927 2033-01-02 U-1349 2019-04-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 11969503 2033-01-02 Drug product 2024-05-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 12396947 2033-01-02 Drug product 2025-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 9259427 2033-01-02 Drug product 2017-05-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208400-001 9855215 2033-01-02 Drug product 2018-01-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 10231927 2033-01-02 U-1349 2019-04-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 11969503 2033-01-02 Drug product 2024-05-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 9259427 2033-01-02 Drug product 2017-05-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208400-001 9855215 2033-01-02 Drug product 2018-01-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 10231927 2033-01-02 U-1699 2019-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 10231927 2033-01-02 U-1349 2019-04-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 10610485 2033-01-02 Drug product 2020-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 11116724 2033-01-02 U-1349 2021-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208400-001 11116724 2033-01-02 U-1699 2021-11-23 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 70 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Xatmep
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHOTREXATE 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YL5FZ2Y5U1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1921592 Internal RxNorm lookup 1921598 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 52652-2001-1 Xatmep 120 mL in 1 BOTTLE SOLUTION 120 12 52652-2001-6 Xatmep 60 mL in 1 BOTTLE SOLUTION 60 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52652-2001 XATMEP (METHOTREXATE) SOLUTION [AZURITY PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20220630_aec9984e-34c5-481b-b6bf-9bb5caf1daf8.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xatmep METHOTREXATE Azurity Pharmaceuticals, Inc. aec9984e-34c5-481b-b6bf-9bb5caf1daf8 2026-05-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208400 application number: NDA208400 ndc (product): 52652-2001
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52652-2001-1 52652200101 120 mL in 1 BOTTLE (52652-2001-1) 120 ml 2017-05-01 0000-00-00 No No Current 52652-2001-6 52652200106 60 mL in 1 BOTTLE (52652-2001-6) 60 ml 2018-08-13 0000-00-00 No No Current