FDA.reportPublic FDA data

Ibuprofen

Product NDC
43353-391
11-digit product format
433530391
Labeler code
43353
Product ID
43353-391_89c56b96-a43b-4c44-ba21-c252a0f2628b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, Inc.
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
800 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
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
43353-391-602023-01-30C16284748780-1f386c649-b1b0-0266-e053-dadaa90a7c1aIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
43353-391-742023-01-30C16284748780-1f386c649-b1b0-0266-e053-dadaa90a7c1aIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
43353-391-802023-01-30C16284748780-1f386c649-b1b0-0266-e053-dadaa90a7c1aIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only
43353-391-922023-01-30C16284748780-1f386c649-b1b0-0266-e053-dadaa90a7c1aIbuprofen Tablets, USP (400 mg, 600 mg and 800 mg) Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-391-60Ibuprofen90 in 1 BOTTLE, PLASTICTABLET902
43353-391-74Ibuprofen500 in 1 BOTTLE, PLASTICTABLET5002
43353-391-80Ibuprofen180 in 1 BOTTLE, PLASTICTABLET1802
43353-391-92Ibuprofen270 in 1 BOTTLE, PLASTICTABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-391-60EA - Each43353-39125450e05-642f-4735-9379-c63a524778f012013-02-13
43353-391-74EA - Each43353-39178030f47-0ad9-40c3-98f0-a3dbcfe150be12013-02-13
43353-391-80EA - Each43353-391d34b1bbb-9f94-4f0c-88be-b09eb0f207c912013-02-13
43353-391-92EA - Each43353-391edfbf076-f57b-4263-b947-bb90ddc5922a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-391IBUPROFEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2Legacy NDC, 4 package rows20191228_aee5ffdc-0fe4-4a74-8b0a-7009d72c3506.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNaee5ffdc-0fe4-4a74-8b0a-7009d72c35062
197806ibuprofen 600 MG Oral TabletPSNaee5ffdc-0fe4-4a74-8b0a-7009d72c35062
197807ibuprofen 800 MG Oral TabletPSNaee5ffdc-0fe4-4a74-8b0a-7009d72c35062
197805ibuprofen 400 MG Oral TabletSCDaee5ffdc-0fe4-4a74-8b0a-7009d72c35062
197806ibuprofen 600 MG Oral TabletSCDaee5ffdc-0fe4-4a74-8b0a-7009d72c35062
197807ibuprofen 800 MG Oral TabletSCDaee5ffdc-0fe4-4a74-8b0a-7009d72c35062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-391-604335303916090 TABLET in 1 BOTTLE, PLASTIC (43353-391-60) 90 tablet2009-11-300000-00-00NoNoCurrent
43353-391-7443353039174500 TABLET in 1 BOTTLE, PLASTIC (43353-391-74) 500 tablet2009-11-300000-00-00NoNoCurrent
43353-391-8043353039180180 TABLET in 1 BOTTLE, PLASTIC (43353-391-80) 180 tablet2009-12-040000-00-00NoNoCurrent
43353-391-9243353039192270 TABLET in 1 BOTTLE, PLASTIC (43353-391-92) 270 tablet2009-11-300000-00-00NoNoCurrent