FDA.reportPublic FDA data

Ibuprofen

Product NDC
58602-713
11-digit product format
586020713
Labeler code
58602
Product ID
58602-713_1100648c-6b9f-49c9-94d0-c40f24fe5c27
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
58602-713-01Ibuprofen24 in 1 BOTTLE, PLASTICTABLET241
58602-713-01Ibuprofen1 in 1 CARTONTABLET11
58602-713-02Ibuprofen100 in 1 BOTTLE, PLASTICTABLET1001
58602-713-02Ibuprofen1 in 1 CARTONTABLET11
58602-713-03Ibuprofen1 in 1 CARTONTABLET11
58602-713-03Ibuprofen150 in 1 BOTTLE, PLASTICTABLET1501
58602-713-05Ibuprofen1 in 1 CARTONTABLET11
58602-713-05Ibuprofen40 in 1 BOTTLE, PLASTICTABLET401
58602-713-06Ibuprofen90 in 1 BOTTLE, PLASTICTABLET901
58602-713-06Ibuprofen1 in 1 CARTONTABLET11
58602-713-07Ibuprofen100 in 1 BOTTLETABLET1001
58602-713-07Ibuprofen1 in 1 CARTONTABLET11
58602-713-08Ibuprofen50 in 1 BOTTLE, PLASTICTABLET501
58602-713-08Ibuprofen1 in 1 CARTONTABLET11
58602-713-09Ibuprofen1 in 1 CARTONTABLET11
58602-713-09Ibuprofen50 in 1 BOTTLETABLET501
58602-713-10Ibuprofen1 in 1 CARTONTABLET11
58602-713-10Ibuprofen60 in 1 BOTTLETABLET601
58602-713-15Ibuprofen60 in 1 BOTTLE, PLASTICTABLET601
58602-713-15Ibuprofen1 in 1 CARTONTABLET11
58602-713-34Ibuprofen200 in 1 BOTTLE, PLASTICTABLET2001
58602-713-36Ibuprofen250 in 1 BOTTLE, PLASTICTABLET2501
58602-713-40Ibuprofen500 in 1 BOTTLE, PLASTICTABLET5001
58602-713-41Ibuprofen1000 in 1 BOTTLE, PLASTICTABLET10001
58602-713-45Ibuprofen1500 in 1 BOTTLETABLET15001
58602-713-48Ibuprofen500 in 1 BOTTLETABLET5001
58602-713-49Ibuprofen300 in 1 BOTTLETABLET3001
58602-713-52Ibuprofen700 in 1 BOTTLE, PLASTICTABLET7001
58602-713-53Ibuprofen150 in 1 BOTTLETABLET1501
58602-713-53Ibuprofen1 in 1 CARTONTABLET11
58602-713-56Ibuprofen90 in 1 BOTTLETABLET901
58602-713-56Ibuprofen1 in 1 CARTONTABLET11
58602-713-57Ibuprofen40 in 1 BOTTLETABLET401
58602-713-57Ibuprofen1 in 1 CARTONTABLET11
58602-713-58Ibuprofen1000 in 1 BOTTLETABLET10001
58602-713-59Ibuprofen225 in 1 BOTTLETABLET2251
58602-713-63Ibuprofen550 in 1 BOTTLETABLET5501
58602-713-71Ibuprofen250 in 1 BOTTLETABLET2501
58602-713-73Ibuprofen24 in 1 BOTTLETABLET241
58602-713-73Ibuprofen1 in 1 CARTONTABLET11
58602-713-75Ibuprofen300 in 1 BOTTLE, PLASTICTABLET3001
58602-713-83Ibuprofen1 in 1 CARTONTABLET11
58602-713-83Ibuprofen200 in 1 BOTTLETABLET2001
58602-713-86Ibuprofen750 in 1 BOTTLETABLET7501
58602-713-87Ibuprofen550 in 1 BOTTLE, PLASTICTABLET5501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-713IBUPROFEN TABLET [AUROHEALTH LLC]1Current NDC, Legacy NDC, 45 package rows20220325_1100648c-6b9f-49c9-94d0-c40f24fe5c27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN1100648c-6b9f-49c9-94d0-c40f24fe5c271
310965ibuprofen 200 MG Oral TabletSCD1100648c-6b9f-49c9-94d0-c40f24fe5c271
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1100648c-6b9f-49c9-94d0-c40f24fe5c271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-713-01586020713011 BOTTLE, PLASTIC in 1 CARTON (58602-713-01) / 24 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-713-02586020713021 BOTTLE, PLASTIC in 1 CARTON (58602-713-02) / 100 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-713-03586020713031 BOTTLE, PLASTIC in 1 CARTON (58602-713-03) / 150 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-713-05586020713051 BOTTLE, PLASTIC in 1 CARTON (58602-713-05) / 40 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-713-06586020713061 BOTTLE, PLASTIC in 1 CARTON (58602-713-06) / 90 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-713-07586020713071 BOTTLE in 1 CARTON (58602-713-07) / 100 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-713-08586020713081 BOTTLE, PLASTIC in 1 CARTON (58602-713-08) / 50 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-713-09586020713091 BOTTLE in 1 CARTON (58602-713-09) / 50 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-713-10586020713101 BOTTLE in 1 CARTON (58602-713-10) / 60 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-713-15586020713151 BOTTLE, PLASTIC in 1 CARTON (58602-713-15) / 60 TABLET in 1 BOTTLE, PLASTIC2022-03-220000-00-00NoNoCurrent
58602-713-3458602071334200 TABLET in 1 BOTTLE, PLASTIC (58602-713-34) 200 tablet2022-03-220000-00-00NoNoCurrent
58602-713-3658602071336250 TABLET in 1 BOTTLE, PLASTIC (58602-713-36) 250 tablet2022-03-220000-00-00NoNoCurrent
58602-713-4058602071340500 TABLET in 1 BOTTLE, PLASTIC (58602-713-40) 500 tablet2022-03-220000-00-00NoNoCurrent
58602-713-41586020713411000 TABLET in 1 BOTTLE, PLASTIC (58602-713-41) 1000 tablet2022-03-220000-00-00NoNoCurrent
58602-713-45586020713451500 TABLET in 1 BOTTLE (58602-713-45) 1500 tablet2022-03-220000-00-00NoNoCurrent
58602-713-4858602071348500 TABLET in 1 BOTTLE (58602-713-48) 500 tablet2022-03-220000-00-00NoNoCurrent
58602-713-4958602071349300 TABLET in 1 BOTTLE (58602-713-49) 300 tablet2022-03-220000-00-00NoNoCurrent
58602-713-5258602071352700 TABLET in 1 BOTTLE, PLASTIC (58602-713-52) 700 tablet2022-03-220000-00-00NoNoCurrent
58602-713-53586020713531 BOTTLE in 1 CARTON (58602-713-53) / 150 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-713-56586020713561 BOTTLE in 1 CARTON (58602-713-56) / 90 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-713-57586020713571 BOTTLE in 1 CARTON (58602-713-57) / 40 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-713-58586020713581000 TABLET in 1 BOTTLE (58602-713-58) 1000 tablet2022-03-220000-00-00NoNoCurrent
58602-713-5958602071359225 TABLET in 1 BOTTLE (58602-713-59) 225 tablet2022-03-220000-00-00NoNoCurrent
58602-713-6358602071363550 TABLET in 1 BOTTLE (58602-713-63) 550 tablet2022-03-220000-00-00NoNoCurrent
58602-713-7158602071371250 TABLET in 1 BOTTLE (58602-713-71) 250 tablet2022-03-220000-00-00NoNoCurrent
58602-713-73586020713731 BOTTLE in 1 CARTON (58602-713-73) / 24 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-713-7558602071375300 TABLET in 1 BOTTLE, PLASTIC (58602-713-75) 300 tablet2022-03-220000-00-00NoNoCurrent
58602-713-83586020713831 BOTTLE in 1 CARTON (58602-713-83) / 200 TABLET in 1 BOTTLE1 bottle2022-03-220000-00-00NoNoCurrent
58602-713-8658602071386750 TABLET in 1 BOTTLE (58602-713-86) 750 tablet2022-03-220000-00-00NoNoCurrent
58602-713-8758602071387550 TABLET in 1 BOTTLE, PLASTIC (58602-713-87) 550 tablet2022-03-220000-00-00NoNoCurrent