FDA.reportPublic FDA data

Ibuprofen

Product NDC
63187-980
11-digit product format
631870980
Labeler code
63187
Product ID
63187-980_35ff4860-111c-48cb-94c3-6601d892901a
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
600 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
IBUPROFEN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197806

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
63187-980-15Ibuprofen15 in 1 BOTTLETABLET, FILM COATED159
63187-980-20Ibuprofen20 in 1 BOTTLETABLET, FILM COATED209
63187-980-21Ibuprofen21 in 1 BOTTLETABLET, FILM COATED219
63187-980-28Ibuprofen28 in 1 BOTTLETABLET, FILM COATED289
63187-980-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED309
63187-980-40Ibuprofen40 in 1 BOTTLETABLET, FILM COATED409
63187-980-42Ibuprofen42 in 1 BOTTLETABLET, FILM COATED429
63187-980-50Ibuprofen50 in 1 BOTTLETABLET, FILM COATED509
63187-980-60Ibuprofen60 in 1 BOTTLETABLET, FILM COATED609
63187-980-90Ibuprofen90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-980-15EA - Each63187-980f1367d51-b7ca-4613-a98e-dbe45f9b861312023-04-07
63187-980-20EA - Each63187-980b82c6d76-6034-46df-bb3d-b4f794db3df312018-06-11
63187-980-21EA - Each63187-980378ca956-6ec7-42d9-8fcf-eb258fd83aa612021-08-05
63187-980-28EA - Each63187-980e854799f-31f9-4220-a49b-9305d539faed12022-03-09
63187-980-30EA - Each63187-980c7c06d69-b165-461e-99a4-1ab81e2ef53912018-06-11
63187-980-40EA - Each63187-98035a0d36d-32bf-4b85-8f4f-4d3a6beaf49f12018-05-09
63187-980-42EA - Each63187-9804bf1f469-5f48-4649-965b-b8a9f792bd6312019-04-11
63187-980-50EA - Each63187-98060c93a35-222c-412a-91a4-7650218d4a7a12022-08-04
63187-980-60EA - Each63187-980392e0f4d-fc3d-4109-a34e-74ce55dd89d912023-08-08
63187-980-90EA - Each63187-98034b88579-177f-4421-89e4-b4a56fcb9ee412020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-980IBUPROFEN TABLET, FILM COATED [PROFICIENT RX LP]9Current NDC, Legacy NDC, 10 package rows20220528_d2c7f045-e70c-4e2b-b2e0-d81a271d0a04.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNd2c7f045-e70c-4e2b-b2e0-d81a271d0a049
197806ibuprofen 600 MG Oral TabletSCDd2c7f045-e70c-4e2b-b2e0-d81a271d0a049

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-980-156318709801515 TABLET, FILM COATED in 1 BOTTLE (63187-980-15) 2018-02-010000-00-00NoNoCurrent
63187-980-206318709802020 TABLET, FILM COATED in 1 BOTTLE (63187-980-20) 2018-02-010000-00-00NoNoCurrent
63187-980-216318709802121 TABLET, FILM COATED in 1 BOTTLE (63187-980-21) 2021-06-230000-00-00NoNoCurrent
63187-980-286318709802828 TABLET, FILM COATED in 1 BOTTLE (63187-980-28) 2022-02-080000-00-00NoNoCurrent
63187-980-306318709803030 TABLET, FILM COATED in 1 BOTTLE (63187-980-30) 2018-02-010000-00-00NoNoCurrent
63187-980-406318709804040 TABLET, FILM COATED in 1 BOTTLE (63187-980-40) 2018-02-010000-00-00NoNoCurrent
63187-980-426318709804242 TABLET, FILM COATED in 1 BOTTLE (63187-980-42) 2019-01-010000-00-00NoNoCurrent
63187-980-506318709805050 TABLET, FILM COATED in 1 BOTTLE (63187-980-50) 2022-05-170000-00-00NoNoCurrent
63187-980-606318709806060 TABLET, FILM COATED in 1 BOTTLE (63187-980-60) 2018-02-010000-00-00NoNoCurrent
63187-980-906318709809090 TABLET, FILM COATED in 1 BOTTLE (63187-980-90) 2018-02-010000-00-00NoNoCurrent