Childrens Ibuprofen

Product NDC
55319-150
11-digit product format
553190150
Labeler code
55319
Product ID
55319-150_dcf65be2-1305-44c4-beec-f4d58071b224
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
FAMILY WELLNESS
Application
ANDA209207
Marketing category
ANDA
Marketing start
2017-06-27
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-150-082025-07-29C16284748780-13b156c62-27a3-fb37-e063-e6dba90a4e07Children's Ibuprofen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-150-08Childrens Ibuprofen1 in 1 CARTONSUSPENSION14
55319-150-08Childrens Ibuprofen120 mL in 1 BOTTLESUSPENSION1204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-150CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [FAMILY WELLNESS]4Legacy NDC, 2 package rows20241222_bdf68111-fcf0-43ce-ba29-ca6a956d58de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSNbdf68111-fcf0-43ce-ba29-ca6a956d58de4
197803ibuprofen 20 MG/ML Oral SuspensionSCDbdf68111-fcf0-43ce-ba29-ca6a956d58de4
197803ibuprofen 100 MG per 5 ML Oral SuspensionSYbdf68111-fcf0-43ce-ba29-ca6a956d58de4
197803ibuprofen 200 MG per 10 ML Oral SuspensionSYbdf68111-fcf0-43ce-ba29-ca6a956d58de4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-150-08553190150081 BOTTLE in 1 CARTON (55319-150-08) > 120 mL in 1 BOTTLE1 bottle2019-03-050000-00-00NoNoCurrent