FDA.reportPublic FDA data

Ibuprofen

Product NDC
60760-596
11-digit product format
607600596
Labeler code
60760
Product ID
60760-596_43ceef1f-6373-1b6c-e063-6394a90a7e36
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
2019-04-29
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
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
60760-596-09Ibuprofen9 in 1 BOTTLE, PLASTICTABLET, FILM COATED97
60760-596-20Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED207
60760-596-30Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED307
60760-596-60Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED607
60760-596-90Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-596-09EA - Each60760-5960a16fd83-1c13-42e4-96cc-6e271c13319f12025-06-13
60760-596-20EA - Each60760-596a0491892-b9cf-4463-8463-f4d15a1e239512019-07-02
60760-596-30EA - Each60760-596616eb695-1c81-4087-9e51-f6edbe4a727e12019-07-02
60760-596-60EA - Each60760-59691572111-65e7-470b-9c2b-b5e3471db40c12019-09-05
60760-596-90EA - Each60760-59683b8bca2-6ee9-4963-a03f-1db427540b7812019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-596IBUPROFEN TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]6Current NDC, Legacy NDC, 5 package rows20250515_88dd304f-1c64-08e3-e053-2a95a90a596f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN88dd304f-1c64-08e3-e053-2a95a90a596f7
197807ibuprofen 800 MG Oral TabletSCD88dd304f-1c64-08e3-e053-2a95a90a596f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-596-09607600596099 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-596-09) 2025-05-13NoNoHistorical
60760-596-206076005962020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-596-20) 2019-04-290000-00-00NoNoCurrent
60760-596-306076005963030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-596-30) 2019-05-130000-00-00NoNoCurrent
60760-596-606076005966060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-596-60) 2019-07-220000-00-00NoNoCurrent
60760-596-906076005969090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-596-90) 2019-04-290000-00-00NoNoCurrent