FDA.reportPublic FDA data

Ibuprofen

Product NDC
58602-708
11-digit product format
586020708
Labeler code
58602
Product ID
58602-708_11f92293-edbc-4fce-a942-afeda4efa92a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA208865
Marketing category
ANDA
Marketing start
2022-03-22
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
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
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
58602-708-01Ibuprofen1 in 1 CARTONTABLET14
58602-708-01Ibuprofen24 in 1 BOTTLE, PLASTICTABLET244
58602-708-02Ibuprofen1 in 1 CARTONTABLET14
58602-708-02Ibuprofen100 in 1 BOTTLE, PLASTICTABLET1004
58602-708-03Ibuprofen150 in 1 BOTTLE, PLASTICTABLET1504
58602-708-03Ibuprofen1 in 1 CARTONTABLET14
58602-708-04Ibuprofen200 in 1 BOTTLE, PLASTICTABLET2004
58602-708-05Ibuprofen40 in 1 BOTTLE, PLASTICTABLET404
58602-708-05Ibuprofen1 in 1 CARTONTABLET14
58602-708-06Ibuprofen1 in 1 CARTONTABLET14
58602-708-06Ibuprofen90 in 1 BOTTLE, PLASTICTABLET904
58602-708-07Ibuprofen1 in 1 CARTONTABLET14
58602-708-07Ibuprofen100 in 1 BOTTLETABLET1004
58602-708-08Ibuprofen1 in 1 CARTONTABLET14
58602-708-08Ibuprofen50 in 1 BOTTLE, PLASTICTABLET504
58602-708-09Ibuprofen1 in 1 CARTONTABLET14
58602-708-09Ibuprofen50 in 1 BOTTLETABLET504
58602-708-15Ibuprofen1 in 1 CARTONTABLET14
58602-708-15Ibuprofen60 in 1 BOTTLE, PLASTICTABLET604
58602-708-17Ibuprofen1000 in 1 BOTTLETABLET10004
58602-708-36Ibuprofen250 in 1 BOTTLE, PLASTICTABLET2504
58602-708-40Ibuprofen500 in 1 BOTTLETABLET5004
58602-708-41Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET10004
58602-708-49Ibuprofen300 in 1 BOTTLETABLET3004
58602-708-52Ibuprofen700 in 1 BOTTLE, PLASTICTABLET7004
58602-708-53Ibuprofen1 in 1 CARTONTABLET14
58602-708-53Ibuprofen150 in 1 BOTTLETABLET1504
58602-708-73Ibuprofen1 in 1 CARTONTABLET14
58602-708-73Ibuprofen24 in 1 BOTTLETABLET244
58602-708-75Ibuprofen300 in 1 BOTTLE, PLASTICTABLET3004
58602-708-79Ibuprofen500 in 1 BOTTLE, PLASTICTABLET5004
58602-708-83Ibuprofen200 in 1 BOTTLETABLET2004
58602-708-83Ibuprofen1 in 1 CARTONTABLET14
58602-708-87Ibuprofen550 in 1 BOTTLE, PLASTICTABLET5504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-708IBUPROFEN TABLET [AUROHEALTH LLC]4Current NDC, Legacy NDC, 34 package rows20250101_09bd3935-526d-4ad1-898a-4f0d9499ebb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN09bd3935-526d-4ad1-898a-4f0d9499ebb94
310965ibuprofen 200 MG Oral TabletSCD09bd3935-526d-4ad1-898a-4f0d9499ebb94
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY09bd3935-526d-4ad1-898a-4f0d9499ebb94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-708-01586020708011 BOTTLE, PLASTIC in 1 CARTON (58602-708-01) / 24 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-708-02586020708021 BOTTLE, PLASTIC in 1 CARTON (58602-708-02) / 100 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-708-03586020708031 BOTTLE, PLASTIC in 1 CARTON (58602-708-03) / 150 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-708-0458602070804200 TABLET in 1 BOTTLE, PLASTIC (58602-708-04) 200 tablet2022-03-220000-00-00NoNoCurrent
58602-708-05586020708051 BOTTLE, PLASTIC in 1 CARTON (58602-708-05) / 40 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-708-06586020708061 BOTTLE, PLASTIC in 1 CARTON (58602-708-06) / 90 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-708-07586020708071 BOTTLE in 1 CARTON (58602-708-07) / 100 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-708-08586020708081 BOTTLE, PLASTIC in 1 CARTON (58602-708-08) / 50 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-708-09586020708091 BOTTLE in 1 CARTON (58602-708-09) / 50 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-708-15586020708151 BOTTLE, PLASTIC in 1 CARTON (58602-708-15) / 60 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-708-17586020708171000 TABLET in 1 BOTTLE (58602-708-17) 1000 tablet2024-12-25NoNoCurrent
58602-708-3658602070836250 TABLET in 1 BOTTLE, PLASTIC (58602-708-36) 250 tablet2022-03-220000-00-00NoNoCurrent
58602-708-4058602070840500 TABLET in 1 BOTTLE (58602-708-40) 500 tablet2024-10-07NoNoCurrent
58602-708-41586020708411000 TABLET in 1 BOTTLE, PLASTIC (58602-708-41) 1000 tablet2022-03-220000-00-00NoNoCurrent
58602-708-4958602070849300 TABLET in 1 BOTTLE (58602-708-49) 300 tablet2022-03-220000-00-00NoNoCurrent
58602-708-5258602070852700 TABLET in 1 BOTTLE, PLASTIC (58602-708-52) 700 tablet2022-03-220000-00-00NoNoCurrent
58602-708-53586020708531 BOTTLE in 1 CARTON (58602-708-53) / 150 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-708-73586020708731 BOTTLE in 1 CARTON (58602-708-73) / 24 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-708-7558602070875300 TABLET in 1 BOTTLE, PLASTIC (58602-708-75) 300 tablet2022-03-220000-00-00NoNoCurrent
58602-708-7958602070879500 TABLET in 1 BOTTLE, PLASTIC (58602-708-79) 500 tablet2024-05-15NoNoCurrent
58602-708-83586020708831 BOTTLE in 1 CARTON (58602-708-83) / 200 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-708-8758602070887550 TABLET in 1 BOTTLE, PLASTIC (58602-708-87) 550 tablet2022-03-220000-00-00NoNoCurrent