FDA.reportPublic FDA data

Ibuprofen

Product NDC
63187-962
11-digit product format
631870962
Labeler code
63187
Product ID
63187-962_042c021e-4cc7-47ea-8395-845c01d13f0e
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
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
63187-962-20Ibuprofen20 in 1 BOTTLETABLET204
63187-962-21Ibuprofen21 in 1 BOTTLETABLET214
63187-962-30Ibuprofen30 in 1 BOTTLETABLET304
63187-962-40Ibuprofen40 in 1 BOTTLETABLET404
63187-962-45Ibuprofen45 in 1 BOTTLETABLET454
63187-962-50Ibuprofen50 in 1 BOTTLETABLET504
63187-962-60Ibuprofen60 in 1 BOTTLETABLET604
63187-962-90Ibuprofen90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-962-30EA - Each63187-96262c42a44-ade3-4157-ba24-eb35e53cda3412018-12-13
63187-962-40EA - Each63187-9623e067b3a-1e6d-4922-a0cb-8db03c8ef35212018-05-09
63187-962-60EA - Each63187-96287bbec7f-d826-463a-9037-f3dbfb1a913112022-05-04
63187-962-90EA - Each63187-962a3a9e13f-f61d-47b5-bad9-9f5d7da488d112018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-962IBUPROFEN TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 8 package rows20230613_e4bb22bb-6df6-4016-a023-0b454df9fb0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNe4bb22bb-6df6-4016-a023-0b454df9fb0b4
197807ibuprofen 800 MG Oral TabletSCDe4bb22bb-6df6-4016-a023-0b454df9fb0b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-962-206318709622020 TABLET in 1 BOTTLE (63187-962-20) 20 tablet2018-01-010000-00-00NoNoCurrent
63187-962-216318709622121 TABLET in 1 BOTTLE (63187-962-21) 21 tablet2018-01-010000-00-00NoNoCurrent
63187-962-306318709623030 TABLET in 1 BOTTLE (63187-962-30) 30 tablet2018-01-010000-00-00NoNoCurrent
63187-962-406318709624040 TABLET in 1 BOTTLE (63187-962-40) 40 tablet2018-01-010000-00-00NoNoCurrent
63187-962-456318709624545 TABLET in 1 BOTTLE (63187-962-45) 45 tablet2018-01-010000-00-00NoNoCurrent
63187-962-506318709625050 TABLET in 1 BOTTLE (63187-962-50) 50 tablet2018-01-010000-00-00NoNoCurrent
63187-962-606318709626060 TABLET in 1 BOTTLE (63187-962-60) 60 tablet2018-01-010000-00-00NoNoCurrent
63187-962-906318709629090 TABLET in 1 BOTTLE (63187-962-90) 90 tablet2018-01-010000-00-00NoNoCurrent