FDA.reportPublic FDA data

IBUPROFEN

Product NDC
60760-603
11-digit product format
607600603
Labeler code
60760
Product ID
60760-603_50c48bc8-09e1-d6fa-e063-6294a90a0646
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA090796
Marketing category
ANDA
Marketing start
2019-10-21
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
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
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
60760-603-20IBUPROFEN20 in 1 BOTTLE, PLASTICTABLET, FILM COATED206
60760-603-28IBUPROFEN28 in 1 BOTTLE, PLASTICTABLET, FILM COATED286
60760-603-30IBUPROFEN30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306
60760-603-40IBUPROFEN40 in 1 BOTTLE, PLASTICTABLET, FILM COATED406
60760-603-60IBUPROFEN60 in 1 BOTTLE, PLASTICTABLET, FILM COATED606
60760-603-90IBUPROFEN90 in 1 BOTTLE, PLASTICTABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-603-20EA - Each60760-603a54cb9f3-3775-428e-93cc-0a11f92736d412019-12-10
60760-603-28EA - Each60760-6031c907f9a-d076-4c55-af37-00c4501de4e912020-01-03
60760-603-30EA - Each60760-60371858b55-cde7-4972-9c79-64e36de37e7212022-02-07
60760-603-40EA - Each60760-6030509bd68-5781-47be-8d3a-a3e786cdde4b12020-02-13
60760-603-60EA - Each60760-6039f7d56ba-41f2-40f6-a4be-4a115e8e690f12019-11-12
60760-603-90EA - Each60760-603e229f954-c6a0-4e67-9086-98331e5808e512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-603IBUPROFEN TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]5Current NDC, Legacy NDC, 6 package rows20230219_95830141-2439-9d45-e053-2995a90ae084.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN95830141-2439-9d45-e053-2995a90ae0846
197806ibuprofen 600 MG Oral TabletSCD95830141-2439-9d45-e053-2995a90ae0846

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-603-206076006032020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-603-20) 2019-10-210000-00-00NoNoCurrent
60760-603-286076006032828 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-603-28) 2019-12-100000-00-00NoNoCurrent
60760-603-306076006033030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-603-30) 2021-10-200000-00-00NoNoCurrent
60760-603-406076006034040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-603-40) 2019-12-260000-00-00NoNoCurrent
60760-603-606076006036060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-603-60) 2019-10-210000-00-00NoNoCurrent
60760-603-906076006039090 in 1 BOTTLE, PLASTICHistorical