Ibuprofen

Product NDC
68210-4199
11-digit product format
682104199
Labeler code
68210
Product ID
68210-4199_ee8eeeab-02f8-0d50-e053-2995a90ac69c
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
ANDA079129
Marketing category
ANDA
Marketing start
2022-06-15
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4199-3Ibuprofen1 in 1 CARTONTABLET, FILM COATED16
68210-4199-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4199IBUPROFEN TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]6Legacy NDC, 2 package rows20241215_86907912-79ce-4592-ab0c-9c6205b2f65c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN86907912-79ce-4592-ab0c-9c6205b2f65c6
310965ibuprofen 200 MG Oral TabletSCD86907912-79ce-4592-ab0c-9c6205b2f65c6
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY86907912-79ce-4592-ab0c-9c6205b2f65c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4199-3682104199031 BOTTLE in 1 CARTON (68210-4199-3) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-06-150000-00-00NoNoCurrent