FDA.reportPublic FDA data

Ibuprofen

Product NDC
33261-155
11-digit product format
332610155
Labeler code
33261
Product ID
33261-155_f3c660d7-4795-4f28-bc87-7a97a6b3c256
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
400 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
33261-155-022020-01-31C16284748780-19d75b9d0-2eab-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
33261-155-102020-01-31C16284748780-19d75b9d0-2eab-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
33261-155-202020-01-31C16284748780-19d75b9d0-2eab-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
33261-155-302020-01-31C16284748780-19d75b9d0-2eab-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
33261-155-602020-01-31C16284748780-19d75b9d0-2eab-f424-e053-dadaa90a57ceIbuprofen Tablets, USP
33261-155-902020-01-31C16284748780-19d75b9d0-2eab-f424-e053-dadaa90a57ceIbuprofen Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-155-02Ibuprofen120 in 1 BOTTLETABLET1202
33261-155-10Ibuprofen10 in 1 BOTTLETABLET102
33261-155-20Ibuprofen20 in 1 BOTTLETABLET202
33261-155-30Ibuprofen30 in 1 BOTTLETABLET302
33261-155-60Ibuprofen60 in 1 BOTTLETABLET602
33261-155-90Ibuprofen90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-155-02EA - Each33261-1555ff308cb-cf26-4c36-9c9f-f92f9983da3512015-10-02
33261-155-20EA - Each33261-155c47c14c7-42d5-4ba7-b84d-d605077fdc9b12015-10-02
33261-155-30EA - Each33261-1556f6f2364-4ca4-49b0-bde9-32938369202612015-10-02
33261-155-60EA - Each33261-155e6661dc5-3006-4af2-b225-91d292910cc312015-10-02
33261-155-90EA - Each33261-1556992c560-4253-4743-b0d5-55727107457312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [AIDAREX PHARMACEUTICALS LLC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [AIDAREX PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-155IBUPROFEN TABLET [AIDAREX PHARMACEUTICALS LLC]2Legacy NDC, 6 package rows20120912_c22b75cb-c744-4233-bbf8-b220526daad8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNc22b75cb-c744-4233-bbf8-b220526daad82
197806ibuprofen 600 MG Oral TabletPSNc22b75cb-c744-4233-bbf8-b220526daad82
197807ibuprofen 800 MG Oral TabletPSNc22b75cb-c744-4233-bbf8-b220526daad82
197805ibuprofen 400 MG Oral TabletSCDc22b75cb-c744-4233-bbf8-b220526daad82
197806ibuprofen 600 MG Oral TabletSCDc22b75cb-c744-4233-bbf8-b220526daad82
197807ibuprofen 800 MG Oral TabletSCDc22b75cb-c744-4233-bbf8-b220526daad82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-155-0233261015502120 in 1 BOTTLEHistorical
33261-155-103326101551010 in 1 BOTTLEHistorical
33261-155-203326101552020 in 1 BOTTLEHistorical
33261-155-303326101553030 in 1 BOTTLEHistorical
33261-155-603326101556060 in 1 BOTTLEHistorical
33261-155-903326101559090 in 1 BOTTLEHistorical