FDA.reportPublic FDA data

Ibuprofen

Product NDC
72476-358
11-digit product format
724760358
Labeler code
72476
Product ID
72476-358_465173ac-4bc9-6b69-e063-6394a90ab6d2
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
RETAIL BUSINESS SERVICES,LLC.
Application
ANDA202312
Marketing category
ANDA
Marketing start
2020-07-26
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72476-358-052023-03-02C16284748780-1c7ccaba7-2640-fd44-e053-dadaa90aa01bIbuprofen 200 mg Tablets, USP Pain Reliever/Fever Reducer NSAID* See New Warnings
72476-358-102023-03-02C16284748780-1c7ccaba7-2640-fd44-e053-dadaa90aa01bIbuprofen 200 mg Tablets, USP Pain Reliever/Fever Reducer NSAID* See New Warnings
72476-358-052021-07-23C16284748780-1c7ccaba7-2640-fd44-e053-dadaa90aa01bIbuprofen 200 mg Tablets, USP Pain Reliever/Fever Reducer NSAID* See New Warnings
72476-358-102021-07-23C16284748780-1c7ccaba7-2640-fd44-e053-dadaa90aa01bIbuprofen 200 mg Tablets, USP Pain Reliever/Fever Reducer NSAID* See New Warnings

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-358-05Ibuprofen50 in 1 BOTTLETABLET505
72476-358-10Ibuprofen100 in 1 BOTTLETABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-358IBUPROFEN TABLET [RETAIL BUSINESS SERVICES,LLC.]4Current NDC, Legacy NDC, 2 package rows20241212_a568fd1e-9bf0-3c03-e053-2a95a90a45b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNa568fd1e-9bf0-3c03-e053-2a95a90a45b75
310965ibuprofen 200 MG Oral TabletSCDa568fd1e-9bf0-3c03-e053-2a95a90a45b75
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYa568fd1e-9bf0-3c03-e053-2a95a90a45b75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72476-358-057247603580550 TABLET in 1 BOTTLE (72476-358-05) 50 tablet2020-07-260000-00-00NoNoCurrent
72476-358-1072476035810100 TABLET in 1 BOTTLE (72476-358-10) 100 tablet2020-07-260000-00-00NoNoCurrent