FDA.reportPublic FDA data

equate ibuprofen

Product NDC
49035-521
11-digit product format
490350521
Labeler code
49035
Product ID
49035-521_e1ed3aec-11a3-4ef5-8631-4ef8ccb7a061
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA076359
Marketing category
ANDA
Marketing start
2011-10-25
Substance
IBUPROFEN
Active strength
100 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
equate ibuprofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310963

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
49035-521-62equate ibuprofen24 in 1 BOTTLETABLET, CHEWABLE247
49035-521-62equate ibuprofen1 in 1 CARTONTABLET, CHEWABLE17
49035-521-67equate ibuprofen2 in 1 CARTONTABLET, CHEWABLE27
49035-521-67equate ibuprofen24 in 1 BOTTLETABLET, CHEWABLE247

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-521-62EA - Each49035-5215378a596-219e-4317-a795-40af0da4932112013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMEQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
IBUPROFENACTIVE MOIETYWK2XYI10QMEQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AEQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
SOYBEAN OILINACTIVE INGREDIENT241ATL177AEQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6LEQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-521EQUATE IBUPROFEN (IBUPROFEN) TABLET, CHEWABLE [WAL-MART STORES INC]6Current NDC, Legacy NDC, 4 package rows20221014_abef43bc-ee9b-4a9c-9cf9-36c323213909.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310963ibuprofen 100 MG Chewable TabletPSNabef43bc-ee9b-4a9c-9cf9-36c3232139097
310963ibuprofen 100 MG Chewable TabletSCDabef43bc-ee9b-4a9c-9cf9-36c3232139097

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-521-62490350521621 BOTTLE in 1 CARTON (49035-521-62) / 24 TABLET, CHEWABLE in 1 BOTTLE1 bottle2011-10-250000-00-00NoNoCurrent
49035-521-67490350521672 BOTTLE in 1 CARTON (49035-521-67) / 24 TABLET, CHEWABLE in 1 BOTTLE2 bottle2011-10-250000-00-00NoNoCurrent