IBU

Product NDC
43353-273
11-digit product format
433530273
Labeler code
43353
Product ID
43353-273_5df716b0-945d-425d-bd24-17123bc77d6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075682
Marketing category
ANDA
Marketing start
2014-04-22
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
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
43353-273-602020-01-31C16284748780-19d75b9d1-1dac-f424-e053-dadaa90a57ceIBU™ Tablets
43353-273-802020-01-31C16284748780-19d75b9d1-1dac-f424-e053-dadaa90a57ceIBU™ Tablets
43353-273-922020-01-31C16284748780-19d75b9d1-1dac-f424-e053-dadaa90a57ceIBU™ Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-273-60IBU90 in 1 BOTTLETABLET901
43353-273-80IBU180 in 1 BOTTLETABLET1801
43353-273-92IBU270 in 1 BOTTLETABLET2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-273-60EA - Each43353-2735d2962b9-3462-4576-9187-c914724a7da612017-11-06
43353-273-80EA - Each43353-273e00b5f53-647f-4424-ab9f-a6b09ec7688712017-11-06
43353-273-92EA - Each43353-273de508c6c-c3ac-4753-8469-b3b440a7e9dc12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-273IBU (IBUPROFEN) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 3 package rows20171018_36eaef2d-c28b-4eb6-88e6-ec33197852a2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-273-604335302736090 in 1 BOTTLEHistorical
43353-273-8043353027380180 in 1 BOTTLEHistorical
43353-273-9243353027392270 in 1 BOTTLEHistorical