Home NDC 39822-1030 Ibuprofen Lysine
Product NDC 39822-1030
11-digit product format 398221030
Labeler code 39822
Product ID 39822-1030_09c10e65-0cea-3052-e063-6394a90ae199
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibuprofen Lysine
Dosage form SOLUTION
Route INTRAVENOUS
Labeler XGen Pharmaceuticals DJB, Inc.
Application ANDA202402
Marketing category ANDA
Marketing start 2016-04-08
Substance IBUPROFEN LYSINE
Active strength 10 mg/mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
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 1 .
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 A202402-001 IBUPROFEN LYSINE IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202402-001 AP
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A202402-001 IBUPROFEN LYSINE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) INJECTABLE / INTRAVENOUS AP 2016-03-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen Lysine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN LYSINE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N01ORX9D6S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1747294 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 39822-1030-1 Ibuprofen Lysine 2 mL in 1 VIAL SOLUTION 2 19 39822-1030-2 Ibuprofen Lysine 3 in 1 CARTON SOLUTION 3 19
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39822-1030 IBUPROFEN LYSINE SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] 19 Current NDC, Legacy NDC, 2 package rows 20240106_6cfdec66-9483-4abe-98d3-3a7d389cc952.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.
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 39822-1030-1 39822103001 2 mL in 1 VIAL 2 ml Historical 39822-1030-2 39822103002 3 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1) 3 vial 2016-04-08 0000-00-00 No No Current