FDA.reportPublic FDA data

Ibuprofen

Product NDC
59726-745
11-digit product format
597260745
Labeler code
59726
Product ID
59726-745_8cab5cc1-af53-4ad5-9773-b101a47248ff
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
P & L Development, LLC
Application
ANDA206568
Marketing category
ANDA
Marketing start
2018-09-30
Marketing end
2027-03-30
Substance
IBUPROFEN
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
59726-745-10Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED17
59726-745-10Ibuprofen10 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED107
59726-745-16Ibuprofen160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1607
59726-745-20Ibuprofen20 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED207
59726-745-20Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED17
59726-745-40Ibuprofen40 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED407
59726-745-40Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-745IBUPROFEN CAPSULE, LIQUID FILLED [P & L DEVELOPMENT, LLC]6Current NDC, Legacy NDC, 7 package rows20230728_d0301d0d-fc65-420f-87fd-a08da1584d54.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSNd0301d0d-fc65-420f-87fd-a08da1584d547
310964ibuprofen 200 MG Oral CapsuleSCDd0301d0d-fc65-420f-87fd-a08da1584d547

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59726-745-10597260745101 BOTTLE, PLASTIC in 1 BOX (59726-745-10) / 10 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-09-302027-03-30NoNoCurrent
59726-745-1659726074516160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (59726-745-16) 2018-09-302027-03-30NoNoCurrent
59726-745-20597260745201 BOTTLE, PLASTIC in 1 BOX (59726-745-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-09-302027-03-30NoNoCurrent
59726-745-40597260745401 BOTTLE, PLASTIC in 1 BOX (59726-745-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2018-09-302027-03-30NoNoHistorical