FDA.reportPublic FDA data

Ibuprofen

Product NDC
63187-022
11-digit product format
631870022
Labeler code
63187
Product ID
63187-022_7db62aa5-dd71-4f62-b656-c4df75686f02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078558
Marketing category
ANDA
Marketing start
2009-11-23
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805, 197806, 197807

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-022-15Ibuprofen15 in 1 BOTTLETABLET159
63187-022-20Ibuprofen20 in 1 BOTTLETABLET209
63187-022-21Ibuprofen21 in 1 BOTTLETABLET219
63187-022-30Ibuprofen30 in 1 BOTTLETABLET309
63187-022-40Ibuprofen40 in 1 BOTTLETABLET409
63187-022-45Ibuprofen45 in 1 BOTTLETABLET459
63187-022-60Ibuprofen60 in 1 BOTTLETABLET609
63187-022-72Ibuprofen120 in 1 BOTTLETABLET1209
63187-022-90Ibuprofen90 in 1 BOTTLETABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-022IBUPROFEN TABLET [PROFICIENT RX LP]9Current NDC, Legacy NDC, 9 package rows20210114_e23eb275-ce0c-40ec-b809-a48c5e46c7ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNe23eb275-ce0c-40ec-b809-a48c5e46c7ec9
197806ibuprofen 600 MG Oral TabletPSNe23eb275-ce0c-40ec-b809-a48c5e46c7ec9
197807ibuprofen 800 MG Oral TabletPSNe23eb275-ce0c-40ec-b809-a48c5e46c7ec9
197805ibuprofen 400 MG Oral TabletSCDe23eb275-ce0c-40ec-b809-a48c5e46c7ec9
197806ibuprofen 600 MG Oral TabletSCDe23eb275-ce0c-40ec-b809-a48c5e46c7ec9
197807ibuprofen 800 MG Oral TabletSCDe23eb275-ce0c-40ec-b809-a48c5e46c7ec9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-022-156318700221515 TABLET in 1 BOTTLE (63187-022-15) 15 tablet2014-05-010000-00-00NoNoCurrent
63187-022-206318700222020 TABLET in 1 BOTTLE (63187-022-20) 20 tablet2016-09-010000-00-00NoNoCurrent
63187-022-216318700222121 TABLET in 1 BOTTLE (63187-022-21) 21 tablet2017-09-010000-00-00NoNoCurrent
63187-022-306318700223030 TABLET in 1 BOTTLE (63187-022-30) 30 tablet2014-05-010000-00-00NoNoCurrent
63187-022-406318700224040 TABLET in 1 BOTTLE (63187-022-40) 40 tablet2014-05-010000-00-00NoNoCurrent
63187-022-456318700224545 TABLET in 1 BOTTLE (63187-022-45) 45 tablet2014-05-010000-00-00NoNoCurrent
63187-022-606318700226060 TABLET in 1 BOTTLE (63187-022-60) 60 tablet2014-05-010000-00-00NoNoCurrent
63187-022-7263187002272120 TABLET in 1 BOTTLE (63187-022-72) 120 tablet2014-05-010000-00-00NoNoCurrent
63187-022-906318700229090 TABLET in 1 BOTTLE (63187-022-90) 90 tablet2014-05-010000-00-00NoNoCurrent