FDA.reportPublic FDA data

Ibuprofen

Product NDC
58602-802
11-digit product format
586020802
Labeler code
58602
Product ID
58602-802_5e6a6cce-b25c-4d6c-9d58-b4db175c6f8e
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA208865
Marketing category
ANDA
Marketing start
2017-11-08
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
58602-802-07Ibuprofen24 in 1 BOTTLETABLET243
58602-802-07Ibuprofen1 in 1 CARTONTABLET13
58602-802-14Ibuprofen1 in 1 CARTONTABLET13
58602-802-14Ibuprofen50 in 1 BOTTLETABLET503
58602-802-21Ibuprofen1 in 1 CARTONTABLET13
58602-802-21Ibuprofen100 in 1 BOTTLETABLET1003
58602-802-29Ibuprofen1 in 1 CARTONTABLET13
58602-802-29Ibuprofen150 in 1 BOTTLETABLET1503
58602-802-34Ibuprofen200 in 1 BOTTLETABLET2003
58602-802-38Ibuprofen300 in 1 BOTTLETABLET3003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-802IBUPROFEN TABLET [AUROHEALTH LLC]3Current NDC, Legacy NDC, 10 package rows20220310_cf6fbf3b-a0f3-4e08-a981-d183fa285758.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNcf6fbf3b-a0f3-4e08-a981-d183fa2857583
310965ibuprofen 200 MG Oral TabletSCDcf6fbf3b-a0f3-4e08-a981-d183fa2857583
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYcf6fbf3b-a0f3-4e08-a981-d183fa2857583

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-802-07586020802071 BOTTLE in 1 CARTON (58602-802-07) / 24 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-802-14586020802141 BOTTLE in 1 CARTON (58602-802-14) / 50 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-802-21586020802211 BOTTLE in 1 CARTON (58602-802-21) / 100 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-802-29586020802291 BOTTLE in 1 CARTON (58602-802-29) / 150 TABLET in 1 BOTTLE1 bottle2017-11-080000-00-00NoNoCurrent
58602-802-3458602080234200 TABLET in 1 BOTTLE (58602-802-34) 200 tablet2017-11-080000-00-00NoNoCurrent
58602-802-3858602080238300 TABLET in 1 BOTTLE (58602-802-38) 300 tablet2017-11-080000-00-00NoNoCurrent