Dye Free Ibuprofen

Product NDC
0363-4381
11-digit product format
003634381
Labeler code
0363
Product ID
0363-4381_84215331-f3fd-489b-a67f-9eebd1fe1322
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
ANDA075139
Marketing category
ANDA
Marketing start
1999-03-01
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
Dye Free 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
0363-4381-12Dye Free Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1009
0363-4381-12Dye Free Ibuprofen1 in 1 CARTONTABLET, FILM COATED19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4381DYE FREE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [WALGREEN COMPANY]8Current NDC, Legacy NDC, 2 package rows20240823_8944a0e8-2928-4494-915f-d1e0a6d4bf5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN8944a0e8-2928-4494-915f-d1e0a6d4bf5c9
310965ibuprofen 200 MG Oral TabletSCD8944a0e8-2928-4494-915f-d1e0a6d4bf5c9
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY8944a0e8-2928-4494-915f-d1e0a6d4bf5c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-4381-12003634381121 BOTTLE, PLASTIC in 1 CARTON (0363-4381-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-010000-00-00NoNoCurrent