FDA.reportPublic FDA data

Ibuprofen

Product NDC
83324-059
11-digit product format
833240059
Labeler code
83324
Product ID
83324-059_0201850e-727c-4fea-9c97-1e06571244f4
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
ANDA075010
Marketing category
ANDA
Marketing start
2024-09-17
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
83324-059-01Ibuprofen1 in 1 CARTONTABLET, FILM COATED14
83324-059-01Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
83324-059-24Ibuprofen1 in 1 CARTONTABLET, FILM COATED14
83324-059-24Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED244
83324-059-50Ibuprofen50 in 1 BOTTLE, PLASTICTABLET, FILM COATED504
83324-059-50Ibuprofen1 in 1 CARTONTABLET, FILM COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-059IBUPROFEN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.]2Current NDC, 6 package rows20240919_8d518a08-486a-4d11-b042-27fc1e6060c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN8d518a08-486a-4d11-b042-27fc1e6060c94
310965ibuprofen 200 MG Oral TabletSCD8d518a08-486a-4d11-b042-27fc1e6060c94
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY8d518a08-486a-4d11-b042-27fc1e6060c94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-059-01833240059011 BOTTLE, PLASTIC in 1 CARTON (83324-059-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-09-17NoNoCurrent
83324-059-24833240059241 BOTTLE, PLASTIC in 1 CARTON (83324-059-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-09-17NoNoCurrent
83324-059-50833240059501 BOTTLE, PLASTIC in 1 CARTON (83324-059-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-09-17NoNoCurrent