FDA.reportPublic FDA data

Ibuprofen Lysine

Product NDC
66993-490
11-digit product format
669930490
Labeler code
66993
Product ID
66993-490_67ff91a5-d5cb-4a5e-a349-07f99b1e7af0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen lysine
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Prasco Laboratories
Application
NDA021903
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-04-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen Lysine
Listing expiration
2027-12-31

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
66993-490-36Ibuprofen Lysine3 in 1 CARTONSOLUTION312
66993-490-36Ibuprofen Lysine2 mL in 1 VIALSOLUTION212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-490-36ML - Milliliter66993-490001902c7-992a-48d7-9165-dfa16166f7d212016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-490IBUPROFEN LYSINE SOLUTION [PRASCO LABORATORIES]11Current NDC, Legacy NDC, 2 package rows20240106_307431c7-12de-21e5-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1747294ibuprofen lysine 10 MG/ML in 2 ML InjectionPSN307431c7-12de-21e5-e054-00144ff88e8812
17472942 ML ibuprofen 10 MG/ML InjectionSCD307431c7-12de-21e5-e054-00144ff88e8812
1747294ibuprofen 10 MG/ML (as ibuprofen lysine 17.1 MG/ML) per 2 ML InjectionSY307431c7-12de-21e5-e054-00144ff88e8812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66993-490-36669930490363 VIAL in 1 CARTON (66993-490-36) / 2 mL in 1 VIAL3 vial2016-04-140000-00-00NoNoCurrent