Ibuprofen

Product NDC
58602-852
11-digit product format
586020852
Labeler code
58602
Product ID
58602-852_43c94480-78d1-4a23-91d4-1d49fea72cb7
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA207753
Marketing category
ANDA
Marketing start
2022-07-18
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
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-852-32Ibuprofen180 in 1 BOTTLECAPSULE1801
58602-852-38Ibuprofen300 in 1 BOTTLECAPSULE3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-852IBUPROFEN CAPSULE [AUROHEALTH LLC]1Current NDC, Legacy NDC, 2 package rows20220722_43c94480-78d1-4a23-91d4-1d49fea72cb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN43c94480-78d1-4a23-91d4-1d49fea72cb71
310964ibuprofen 200 MG Oral CapsuleSCD43c94480-78d1-4a23-91d4-1d49fea72cb71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-852-3258602085232180 CAPSULE in 1 BOTTLE (58602-852-32) 180 capsule2022-07-180000-00-00NoNoCurrent
58602-852-3858602085238300 CAPSULE in 1 BOTTLE (58602-852-38) 300 capsule2022-07-180000-00-00NoNoCurrent