FDA.reportPublic FDA data

equaline ibuprofen

Product NDC
41163-604
11-digit product format
411630604
Labeler code
41163
Product ID
41163-604_950ab3af-db94-4330-aabd-8d7170912e60
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA072096
Marketing category
ANDA
Marketing start
2004-08-05
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
equaline 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
41163-604-59equaline ibuprofen750 in 1 BOTTLETABLET, FILM COATED7508
41163-604-62equaline ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41163-604-62equaline ibuprofen24 in 1 BOTTLETABLET, FILM COATED248
41163-604-71equaline ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41163-604-71equaline ibuprofen50 in 1 BOTTLETABLET, FILM COATED508
41163-604-76equaline ibuprofen120 in 1 BOTTLETABLET, FILM COATED1208
41163-604-76equaline ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41163-604-78equaline ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41163-604-78equaline ibuprofen100 in 1 BOTTLETABLET, FILM COATED1008
41163-604-82equaline ibuprofen100 in 1 BOTTLETABLET, FILM COATED1008
41163-604-82equaline ibuprofen2 in 1 CARTONTABLET, FILM COATED28
41163-604-85equaline ibuprofen1 in 1 CARTONTABLET, FILM COATED18
41163-604-85equaline ibuprofen250 in 1 BOTTLETABLET, FILM COATED2508
41163-604-90equaline ibuprofen500 in 1 BOTTLETABLET, FILM COATED5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-604-59EA - Each41163-604ea3fe2f8-d00f-4b1f-a072-27ba26f1d15012012-07-24
41163-604-62EA - Each41163-604894dfc41-021f-4826-a24d-f3a0c798578e12012-07-24
41163-604-71EA - Each41163-6043b2db736-08bf-4b0c-8c8a-4d2c1163783012016-06-14
41163-604-76EA - Each41163-604405fa11e-9fdc-4f8f-8d25-c577ca4e090212013-02-13
41163-604-78EA - Each41163-604743728a2-d696-48d7-8dda-3eaf81fb851012012-07-24
41163-604-82EA - Each41163-6040e381947-4d83-4376-9f50-a5679998a70612013-02-11
41163-604-85EA - Each41163-604debc1101-8822-4f4e-8e81-dbbddad4f8cf12012-07-24
41163-604-90EA - Each41163-60453e2f918-c45e-4c02-a351-89228236365312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMEQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
IBUPROFENACTIVE MOIETYWK2XYI10QMEQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJEQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUALINE IBUPROFEN (IBUPROFEN) TABLET [SUPERVALU INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-604EQUALINE IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI]8Current NDC, Legacy NDC, 14 package rows20250412_e18f4ce6-d7d3-4b53-b87a-5900ac3397f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNe18f4ce6-d7d3-4b53-b87a-5900ac3397f18
310965ibuprofen 200 MG Oral TabletSCDe18f4ce6-d7d3-4b53-b87a-5900ac3397f18
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYe18f4ce6-d7d3-4b53-b87a-5900ac3397f18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-604-5941163060459750 TABLET, FILM COATED in 1 BOTTLE (41163-604-59) 2004-08-060000-00-00NoNoCurrent
41163-604-62411630604621 BOTTLE in 1 CARTON (41163-604-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-08-100000-00-00NoNoCurrent
41163-604-71411630604711 BOTTLE in 1 CARTON (41163-604-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-08-170000-00-00NoNoCurrent
41163-604-76411630604761 BOTTLE in 1 CARTON (41163-604-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-12-020000-00-00NoNoCurrent
41163-604-78411630604781 BOTTLE in 1 CARTON (41163-604-78) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-08-300000-00-00NoNoCurrent
41163-604-82411630604822 BOTTLE in 1 CARTON (41163-604-82) > 100 TABLET, FILM COATED in 1 BOTTLE2 bottle2015-02-120000-00-00NoNoCurrent
41163-604-85411630604851 BOTTLE in 1 CARTON (41163-604-85) / 250 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-09-030000-00-00NoNoCurrent
41163-604-9041163060490500 TABLET, FILM COATED in 1 BOTTLE (41163-604-90) 2004-08-050000-00-00NoNoCurrent