FDA.reportPublic FDA data

Ibuprofen

Product NDC
63187-967
11-digit product format
631870967
Labeler code
63187
Product ID
63187-967_f858d715-a62b-429c-9c38-9a06e7f3716b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
Substance
IBUPROFEN
Active strength
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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
63187-967-15Ibuprofen15 in 1 BOTTLETABLET, FILM COATED156
63187-967-20Ibuprofen20 in 1 BOTTLETABLET, FILM COATED206
63187-967-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED306
63187-967-40Ibuprofen40 in 1 BOTTLETABLET, FILM COATED406
63187-967-50Ibuprofen50 in 1 BOTTLETABLET, FILM COATED506
63187-967-60Ibuprofen60 in 1 BOTTLETABLET, FILM COATED606
63187-967-90Ibuprofen90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-967-15EA - Each63187-96755ede900-f9fa-4a09-9462-ed7c38af007212019-10-07
63187-967-20EA - Each63187-9678e69a41f-25dd-47f1-9807-7066d3aa51a312020-01-03
63187-967-60EA - Each63187-9678d417f6b-eb71-496b-920c-d1ef7bb2dfa712023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-967IBUPROFEN TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 7 package rows20220426_444b2ea0-ec42-4bcf-b8d2-38b4b297ada0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN444b2ea0-ec42-4bcf-b8d2-38b4b297ada06
197805ibuprofen 400 MG Oral TabletSCD444b2ea0-ec42-4bcf-b8d2-38b4b297ada06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-967-156318709671515 TABLET, FILM COATED in 1 BOTTLE (63187-967-15) 2019-08-010000-00-00NoNoCurrent
63187-967-206318709672020 TABLET, FILM COATED in 1 BOTTLE (63187-967-20) 2018-11-010000-00-00NoNoCurrent
63187-967-306318709673030 TABLET, FILM COATED in 1 BOTTLE (63187-967-30) 2018-01-010000-00-00NoNoCurrent
63187-967-406318709674040 TABLET, FILM COATED in 1 BOTTLE (63187-967-40) 2018-11-010000-00-00NoNoCurrent
63187-967-506318709675050 TABLET, FILM COATED in 1 BOTTLE (63187-967-50) 2018-01-010000-00-00NoNoCurrent
63187-967-606318709676060 TABLET, FILM COATED in 1 BOTTLE (63187-967-60) 2018-01-010000-00-00NoNoCurrent
63187-967-906318709679090 TABLET, FILM COATED in 1 BOTTLE (63187-967-90) 2018-01-010000-00-00NoNoCurrent