Ibuprofen

Product NDC
63941-760
11-digit product format
639410760
Labeler code
63941
Product ID
63941-760_55f57dfd-6eed-4aab-b05a-d54a8ad96b0e
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Best Choice (Valu Merchandisers Company)
Application
ANDA074916
Marketing category
ANDA
Marketing start
2019-01-25
Marketing end
2026-06-28
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
Current FDA listing
Yes

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
63941-760-94IbuprofenChildrens118 mL in 1 BOTTLESUSPENSION11813
63941-760-94IbuprofenChildrens1 in 1 CARTONSUSPENSION113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-760IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [BEST CHOICE (VALU MERCHANDISERS COMPANY)]10Current NDC, Legacy NDC, 2 package rows20250110_89b9007e-49be-453f-a0ed-c572b56e0ad7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN89b9007e-49be-453f-a0ed-c572b56e0ad713
197803ibuprofen 20 MG/ML Oral SuspensionSCD89b9007e-49be-453f-a0ed-c572b56e0ad713
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY89b9007e-49be-453f-a0ed-c572b56e0ad713
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY89b9007e-49be-453f-a0ed-c572b56e0ad713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-760-94639410760941 BOTTLE in 1 CARTON (63941-760-94) / 118 mL in 1 BOTTLE1 bottle2019-01-252026-06-28NoNoCurrent