FDA.reportPublic FDA data

Ibuprofen

Product NDC
63187-992
11-digit product format
631870992
Labeler code
63187
Product ID
63187-992_ad45dc23-f2b0-4de6-aaab-07549fc226f2
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-992-15Ibuprofen15 in 1 BOTTLETABLET, FILM COATED156
63187-992-20Ibuprofen20 in 1 BOTTLETABLET, FILM COATED206
63187-992-21Ibuprofen21 in 1 BOTTLETABLET, FILM COATED216
63187-992-24Ibuprofen24 in 1 BOTTLETABLET, FILM COATED246
63187-992-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED306
63187-992-40Ibuprofen40 in 1 BOTTLETABLET, FILM COATED406
63187-992-45Ibuprofen45 in 1 BOTTLETABLET, FILM COATED456
63187-992-60Ibuprofen60 in 1 BOTTLETABLET, FILM COATED606
63187-992-90Ibuprofen90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-992-15EA - Each63187-992d8ad541a-8c25-416d-851e-6c9b6d1f02a512021-06-02
63187-992-20EA - Each63187-992ac408ee6-5df8-4ad7-aacb-f613f5bf79ee12019-06-19
63187-992-21EA - Each63187-99232e49514-62eb-49d0-9ee0-233688875a3e12018-11-06
63187-992-24EA - Each63187-99250626e7c-91ce-4562-b8ae-7735bf31350b12022-03-09
63187-992-30EA - Each63187-992ace03dcc-f03f-4657-827d-84893efaa24612018-06-11
63187-992-40EA - Each63187-9922ccbbe9f-9f80-47ee-8c8c-aad0e4f57a7612018-12-13
63187-992-60EA - Each63187-9923770eae2-ff7e-47bc-9b53-fca2b252ed2712018-05-09
63187-992-90EA - Each63187-99248c970b7-bb24-47c0-9b6b-4be30bc944a612018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-992IBUPROFEN TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 9 package rows20220409_2dc3108f-d917-40c6-865d-c900cf055d1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN2dc3108f-d917-40c6-865d-c900cf055d1c6
197807ibuprofen 800 MG Oral TabletSCD2dc3108f-d917-40c6-865d-c900cf055d1c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-992-156318709921515 TABLET, FILM COATED in 1 BOTTLE (63187-992-15) 2021-03-030000-00-00NoNoCurrent
63187-992-206318709922020 TABLET, FILM COATED in 1 BOTTLE (63187-992-20) 2018-03-010000-00-00NoNoCurrent
63187-992-216318709922121 TABLET, FILM COATED in 1 BOTTLE (63187-992-21) 2018-03-010000-00-00NoNoCurrent
63187-992-246318709922424 TABLET, FILM COATED in 1 BOTTLE (63187-992-24) 2022-02-080000-00-00NoNoCurrent
63187-992-306318709923030 TABLET, FILM COATED in 1 BOTTLE (63187-992-30) 2018-03-010000-00-00NoNoCurrent
63187-992-406318709924040 TABLET, FILM COATED in 1 BOTTLE (63187-992-40) 2018-03-010000-00-00NoNoCurrent
63187-992-456318709924545 TABLET, FILM COATED in 1 BOTTLE (63187-992-45) 2018-03-010000-00-00NoNoCurrent
63187-992-606318709926060 TABLET, FILM COATED in 1 BOTTLE (63187-992-60) 2018-03-010000-00-00NoNoCurrent
63187-992-906318709929090 TABLET, FILM COATED in 1 BOTTLE (63187-992-90) 2018-03-010000-00-00NoNoCurrent