FDA.reportPublic FDA data

LEADER CHILDRENS IBUPROFEN

Product NDC
70000-0263
11-digit product format
700000263
Labeler code
70000
Product ID
70000-0263_190f0279-7683-440a-aec8-7ee9445c1f9b
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA074937
Marketing category
ANDA
Marketing start
2017-03-28
Substance
IBUPROFEN
Active strength
100 mg/5mL
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
LEADER CHILDRENS IBUPROFEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

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
70000-0263-1LEADER CHILDRENS IBUPROFEN1 in 1 CARTONSUSPENSION15
70000-0263-1LEADER CHILDRENS IBUPROFEN120 mL in 1 BOTTLESUSPENSION1205
70000-0263-2LEADER CHILDRENS IBUPROFEN240 mL in 1 BOTTLESUSPENSION2405
70000-0263-2LEADER CHILDRENS IBUPROFEN1 in 1 CARTONSUSPENSION15
70000-0263-3LEADER CHILDRENS IBUPROFEN150 mL in 1 BOTTLESUSPENSION1505
70000-0263-3LEADER CHILDRENS IBUPROFEN1 in 1 CARTONSUSPENSION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0263-1ML - Milliliter70000-0263fbb179f2-5d83-4b39-a4c8-7f816a8d06e212017-11-06
70000-0263-2ML - Milliliter70000-0263fbe88e6f-ef78-4794-b3b0-585c7211eea812017-11-06
70000-0263-3ML - Milliliter70000-02635146b58d-9db9-4309-b673-3ed748b15b8612018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0263LEADER CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [CARDINAL HEALTH 110, LLC. DBA LEADER]5Current NDC, Legacy NDC, 6 package rows20250305_913a4bd0-0784-45b4-b05e-3e7c016bbb86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN913a4bd0-0784-45b4-b05e-3e7c016bbb865
197803ibuprofen 20 MG/ML Oral SuspensionSCD913a4bd0-0784-45b4-b05e-3e7c016bbb865
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY913a4bd0-0784-45b4-b05e-3e7c016bbb865
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY913a4bd0-0784-45b4-b05e-3e7c016bbb865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0263-1700000263011 BOTTLE in 1 CARTON (70000-0263-1) / 120 mL in 1 BOTTLE1 bottle2017-03-280000-00-00NoNoCurrent
70000-0263-2700000263021 BOTTLE in 1 CARTON (70000-0263-2) / 240 mL in 1 BOTTLE1 bottle2017-03-280000-00-00NoNoCurrent
70000-0263-3700000263031 BOTTLE in 1 CARTON (70000-0263-3) > 150 mL in 1 BOTTLE1 bottle2017-06-270000-00-00NoNoCurrent