FDA.reportPublic FDA data

IBUPROFEN

Product NDC
61919-463
11-digit product format
619190463
Labeler code
61919
Product ID
61919-463_4c493c0f-6b6e-a79a-e063-6294a90a982d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUOROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA091625
Marketing category
ANDA
Marketing start
2019-08-22
Substance
IBUPROFEN
Active strength
800 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IBUPROFEN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197807

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
61919-463-212025-01-30C16284748780-12cef2736-87e0-d83d-e063-dadaa90ab31fIBUPROFEN
61919-463-302025-01-30C16284748780-12cef2736-8b20-d83d-e063-dadaa90ab31fIBUPROFEN
61919-463-402025-01-30C16284748780-12cef2736-87e0-d83d-e063-dadaa90ab31fIBUPROFEN
61919-463-452025-01-30C16284748780-12cef2736-87e0-d83d-e063-dadaa90ab31fIBUPROFEN
61919-463-602025-01-30C16284748780-12cef2736-87e0-d83d-e063-dadaa90ab31fIBUPROFEN
61919-463-712025-01-30C16284748780-12cef2736-87e0-d83d-e063-dadaa90ab31fIBUPROFEN
61919-463-722025-01-30C16284748780-12cef2736-87e0-d83d-e063-dadaa90ab31fIBUPROFEN
61919-463-902025-01-30C16284748780-12cef2736-87e0-d83d-e063-dadaa90ab31fIBUPROFEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-463-15IBUPROFEN15 in 1 BOTTLETABLET, FILM COATED157
61919-463-21IBUPROFEN21 in 1 BOTTLETABLET, FILM COATED217
61919-463-40IBUPROFEN40 in 1 BOTTLETABLET, FILM COATED407
61919-463-45IBUPROFEN45 in 1 BOTTLETABLET, FILM COATED457
61919-463-60IBUPROFEN60 in 1 BOTTLETABLET, FILM COATED607
61919-463-71IBUPROFEN100 in 1 BOTTLETABLET, FILM COATED1007
61919-463-72IBUPROFEN120 in 1 BOTTLETABLET, FILM COATED1207
61919-463-90IBUPROFEN90 in 1 BOTTLETABLET, FILM COATED907
61919-463-30IBUPROFEN30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-463IBUPROFEN (IBUOROFEN) TABLET, FILM COATED [DIRECT_RX]6Current NDC, Legacy NDC, 8 package rows20230419_90b8b80e-ab30-3590-e053-2a95a90a70ef.zip
61919-463IBUPROFEN (IBUOROFEN) TABLET, FILM COATED IBUPROFEN TABLET, FILM COATED [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20190330_67377024-fe71-4fa0-e053-2991aa0afba2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN90b8b80e-ab30-3590-e053-2a95a90a70ef7
197807ibuprofen 800 MG Oral TabletSCD90b8b80e-ab30-3590-e053-2a95a90a70ef7
197806ibuprofen 600 MG Oral TabletPSN67377024-fe71-4fa0-e053-2991aa0afba22
197807ibuprofen 800 MG Oral TabletPSN67377024-fe71-4fa0-e053-2991aa0afba22
197806ibuprofen 600 MG Oral TabletSCD67377024-fe71-4fa0-e053-2991aa0afba22
197807ibuprofen 800 MG Oral TabletSCD67377024-fe71-4fa0-e053-2991aa0afba22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-463-156191904631515 TABLET, FILM COATED in 1 BOTTLE (61919-463-15) 2019-08-22NoNoCurrent
61919-463-216191904632121 TABLET, FILM COATED in 1 BOTTLE (61919-463-21) 2019-08-220000-00-00NoNoCurrent
61919-463-306191904633030 TABLET, FILM COATED in 1 BOTTLE (61919-463-30) 2018-03-120000-00-00NoNoCurrent
61919-463-406191904634040 TABLET, FILM COATED in 1 BOTTLE (61919-463-40) 2019-08-220000-00-00NoNoCurrent
61919-463-456191904634545 TABLET, FILM COATED in 1 BOTTLE (61919-463-45) 2019-08-220000-00-00NoNoCurrent
61919-463-606191904636060 TABLET, FILM COATED in 1 BOTTLE (61919-463-60) 2019-08-220000-00-00NoNoCurrent
61919-463-7161919046371100 TABLET, FILM COATED in 1 BOTTLE (61919-463-71) 2019-08-220000-00-00NoNoCurrent
61919-463-7261919046372120 TABLET, FILM COATED in 1 BOTTLE (61919-463-72) 2019-08-22NoNoCurrent
61919-463-906191904639090 TABLET, FILM COATED in 1 BOTTLE (61919-463-90) 2019-08-220000-00-00NoNoCurrent