FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen Lysine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN LYSINE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN01ORX9D6S
Rxcui1747294

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-1030-1Ibuprofen Lysine2 mL in 1 VIALSOLUTION219
39822-1030-2Ibuprofen Lysine3 in 1 CARTONSOLUTION319

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-1030-1ML - Milliliter39822-1030755dbf5b-36a8-421d-9983-535d6eda71bf12016-05-16
39822-1030-2ML - Milliliter39822-103054848e70-2109-4c79-acfd-87196492880d12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-1030IBUPROFEN LYSINE SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]19Current NDC, Legacy NDC, 2 package rows20240106_6cfdec66-9483-4abe-98d3-3a7d389cc952.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1747294ibuprofen lysine 10 MG/ML in 2 ML InjectionPSN6cfdec66-9483-4abe-98d3-3a7d389cc95219
17472942 ML ibuprofen 10 MG/ML InjectionSCD6cfdec66-9483-4abe-98d3-3a7d389cc95219
1747294ibuprofen 10 MG/ML (as ibuprofen lysine 17.1 MG/ML) per 2 ML InjectionSY6cfdec66-9483-4abe-98d3-3a7d389cc95219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
39822-1030-1398221030012 mL in 1 VIAL2 mlHistorical
39822-1030-2398221030023 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1) 3 vial2016-04-080000-00-00NoNoCurrent