FDA.reportPublic FDA data

Dye Free Ibuprofen

Product NDC
0363-0438
11-digit product format
003630438
Labeler code
0363
Product ID
0363-0438_7fdfae5d-d264-4a9b-8de0-793b5e6c50be
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
0363-0438-12Dye Free Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
0363-0438-12Dye Free Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10014
0363-0438-15Dye Free Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
0363-0438-15Dye Free Ibuprofen50 in 1 BOTTLETABLET, FILM COATED5014
0363-0438-32Dye Free Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
0363-0438-32Dye Free Ibuprofen120 in 1 BOTTLE, PLASTICTABLET, FILM COATED12014
0363-0438-99Dye Free Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10014
0363-0438-99Dye Free Ibuprofen1 in 1 CARTONTABLET, FILM COATED114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0438-12EA - Each0363-0438a4e64d16-8ed6-41a2-9802-54bf970f7c2c12013-02-13
0363-0438-15EA - Each0363-043806456d67-f055-42e8-aacb-f0e343f9522a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMDYE FREE IBUPROFEN (IBUPROFEN) TABLET [WALGREEN CO.]3
IBUPROFENACTIVE MOIETYWK2XYI10QMDYE FREE IBUPROFEN (IBUPROFEN) TABLET [WALGREEN CO.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODYE FREE IBUPROFEN (IBUPROFEN) TABLET [WALGREEN CO.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DYE FREE IBUPROFEN (IBUPROFEN) TABLET [WALGREEN CO.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDYE FREE IBUPROFEN (IBUPROFEN) TABLET [WALGREEN CO.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673DYE FREE IBUPROFEN (IBUPROFEN) TABLET [WALGREEN CO.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0438DYE FREE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [WALGREEN COMPANY]13Current NDC, Legacy NDC, 8 package rows20241228_d3d093f9-207a-40d4-a7be-c6b5a544a0a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNd3d093f9-207a-40d4-a7be-c6b5a544a0a714
310965ibuprofen 200 MG Oral TabletSCDd3d093f9-207a-40d4-a7be-c6b5a544a0a714
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYd3d093f9-207a-40d4-a7be-c6b5a544a0a714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0438-12003630438121 in 1 CARTONHistorical
0363-0438-15003630438151 in 1 CARTONHistorical
0363-0438-32003630438321 BOTTLE, PLASTIC in 1 CARTON (0363-0438-32) / 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2024-12-16NoNoHistorical
0363-0438-99003630438991 BOTTLE, PLASTIC in 1 CARTON (0363-0438-99) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1999-03-010000-00-00NoNoCurrent