FDA.reportPublic FDA data

IBUPROFEN

Product NDC
0363-9612
11-digit product format
003639612
Labeler code
0363
Product ID
0363-9612_13b22280-b329-93b4-e063-6394a90a12f9
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
WALGREENS
Application
ANDA091237
Marketing category
ANDA
Marketing start
2018-12-11
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
0363-9612-012021-11-02C16284748780-19d75b9d0-0bc5-f424-e053-dadaa90a57ceWalgreens Ibuprofen 200mg Caplets
0363-9612-052021-11-02C16284748780-19d75b9d0-0bc5-f424-e053-dadaa90a57ceWalgreens Ibuprofen 200mg Caplets
0363-9612-262021-11-02C16284748780-19d75b9d0-0bc5-f424-e053-dadaa90a57ceWalgreens Ibuprofen 200mg Caplets
0363-9612-502021-11-02C16284748780-19d75b9d0-0bc5-f424-e053-dadaa90a57ceWalgreens Ibuprofen 200mg Caplets
0363-9612-012020-01-31C16284748780-19d75b9d0-0bc5-f424-e053-dadaa90a57ceWalgreens Ibuprofen 200mg Caplets
0363-9612-052020-01-31C16284748780-19d75b9d0-0bc5-f424-e053-dadaa90a57ceWalgreens Ibuprofen 200mg Caplets
0363-9612-262020-01-31C16284748780-19d75b9d0-0bc5-f424-e053-dadaa90a57ceWalgreens Ibuprofen 200mg Caplets
0363-9612-502020-01-31C16284748780-19d75b9d0-0bc5-f424-e053-dadaa90a57ceWalgreens Ibuprofen 200mg Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9612-01IBUPROFEN100 in 1 BOTTLE, PLASTICTABLET1005
0363-9612-05IBUPROFEN50 in 1 BOTTLE, PLASTICTABLET505
0363-9612-26IBUPROFEN225 in 1 BOTTLE, PLASTICTABLET2255
0363-9612-50IBUPROFEN500 in 1 BOTTLE, PLASTICTABLET5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-9612IBUPROFEN TABLET [WALGREENS]5Current NDC, Legacy NDC, 4 package rows20240316_76f15be2-4682-5015-e053-2991aa0af0d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN76f15be2-4682-5015-e053-2991aa0af0d25
310965ibuprofen 200 MG Oral TabletSCD76f15be2-4682-5015-e053-2991aa0af0d25
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY76f15be2-4682-5015-e053-2991aa0af0d25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-9612-0100363961201100 TABLET in 1 BOTTLE, PLASTIC (0363-9612-01) 100 tablet2018-12-110000-00-00NoNoCurrent
0363-9612-050036396120550 TABLET in 1 BOTTLE, PLASTIC (0363-9612-05) 50 tablet2018-12-110000-00-00NoNoCurrent
0363-9612-2600363961226225 TABLET in 1 BOTTLE, PLASTIC (0363-9612-26) 225 tablet2018-12-110000-00-00NoNoCurrent
0363-9612-5000363961250500 TABLET in 1 BOTTLE, PLASTIC (0363-9612-50) 500 tablet2018-12-110000-00-00NoNoCurrent