FDA.reportPublic FDA data

Ibuprofen

Product NDC
69677-226
11-digit product format
696770226
Labeler code
69677
Product ID
69677-226_686b88b3-2ee0-3263-e053-2991aa0ac235
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mas Management Group, Inc.
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
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
69677-226-012020-01-31C16284748780-19d75b9d0-95ef-f424-e053-dadaa90a57ceIBUPROFEN Tablets, USP
69677-226-152020-01-31C16284748780-19d75b9d0-95ef-f424-e053-dadaa90a57ceIBUPROFEN Tablets, USP
69677-226-202020-01-31C16284748780-19d75b9d0-95ef-f424-e053-dadaa90a57ceIBUPROFEN Tablets, USP
69677-226-302020-01-31C16284748780-19d75b9d0-95ef-f424-e053-dadaa90a57ceIBUPROFEN Tablets, USP
69677-226-602020-01-31C16284748780-19d75b9d0-95ef-f424-e053-dadaa90a57ceIBUPROFEN Tablets, USP
69677-226-902020-01-31C16284748780-19d75b9d0-95ef-f424-e053-dadaa90a57ceIBUPROFEN Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69677-226-01Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1202
69677-226-15Ibuprofen15 in 1 BOTTLETABLET, FILM COATED152
69677-226-20Ibuprofen20 in 1 BOTTLETABLET, FILM COATED202
69677-226-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED302
69677-226-60Ibuprofen60 in 1 BOTTLETABLET, FILM COATED602
69677-226-90Ibuprofen90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69677-226IBUPROFEN TABLET, FILM COATED [MAS MANAGEMENT GROUP, INC.]2Legacy NDC, 6 package rows20180328_57ec3a3f-b5ac-3a97-e053-2a91aa0a788f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2
197807ibuprofen 800 MG Oral TabletPSN57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2
197806ibuprofen 600 MG Oral TabletSCD57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2
197807ibuprofen 800 MG Oral TabletSCD57ec3a3f-b5ac-3a97-e053-2a91aa0a788f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69677-226-0169677022601120 in 1 BOTTLEHistorical
69677-226-156967702261515 in 1 BOTTLEHistorical
69677-226-206967702262020 in 1 BOTTLEHistorical
69677-226-306967702263030 in 1 BOTTLEHistorical
69677-226-606967702266060 in 1 BOTTLEHistorical
69677-226-906967702269090 in 1 BOTTLEHistorical