FDA.reportPublic FDA data

Ibuprofen

Product NDC
60760-597
11-digit product format
607600597
Labeler code
60760
Product ID
60760-597_51cca64c-9a12-9785-e063-6394a90af9be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA078329
Marketing category
ANDA
Marketing start
2019-05-02
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
60760-597-20Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2011
60760-597-28Ibuprofen28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2811
60760-597-30Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3011
60760-597-40Ibuprofen40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4011
60760-597-60Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6011
60760-597-90Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-597-20EA - Each60760-59773b623d4-6dbf-4090-bab0-ee57fb719cf612019-07-02
60760-597-28EA - Each60760-597fffe644d-7794-49d6-8e4a-2868a45fab8d12019-07-02
60760-597-30EA - Each60760-59750dfd667-c125-47ef-a956-c1d6c120029612019-09-05
60760-597-40EA - Each60760-5977bc0c160-9e26-47d0-91cb-82b13767ab9912019-07-02
60760-597-60EA - Each60760-5970b714f36-e699-4b1c-9de6-68c8b2b4b4ec12019-07-02
60760-597-90EA - Each60760-59752af5d35-c6fa-4d80-8817-2badae3112a512024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-597IBUPROFEN TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]9Current NDC, Legacy NDC, 6 package rows20250425_88dda062-2b9c-3632-e053-2a95a90a1431.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN88dda062-2b9c-3632-e053-2a95a90a143111
197806ibuprofen 600 MG Oral TabletSCD88dda062-2b9c-3632-e053-2a95a90a143111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-597-206076005972020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-20) 2019-05-020000-00-00NoNoCurrent
60760-597-286076005972828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-28) 2019-06-100000-00-00NoNoCurrent
60760-597-306076005973030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-30) 2025-04-230000-00-00NoNoCurrent
60760-597-406076005974040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-40) 2019-05-020000-00-00NoNoCurrent
60760-597-606076005976060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-60) 2019-06-120000-00-00NoNoCurrent
60760-597-906076005979090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-597-90) 2024-04-26NoNoHistorical