FDA.reportPublic FDA data

equate ibuprofen

Product NDC
49035-897
11-digit product format
490350897
Labeler code
49035
Product ID
49035-897_82073546-a148-4538-8f61-75aa4ac6df0a
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
ANDA074937
Marketing category
ANDA
Marketing start
1999-02-02
Substance
IBUPROFEN
Active strength
100 mg/5mL
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/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197803

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
49035-897-26equate ibuprofen1 in 1 CARTONSUSPENSION15
49035-897-26equate ibuprofen118 mL in 1 BOTTLESUSPENSION1185
49035-897-34equate ibuprofen1 in 1 CARTONSUSPENSION15
49035-897-34equate ibuprofen237 mL in 1 BOTTLESUSPENSION2375

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-897-26ML - Milliliter49035-8979e9f9a35-7a63-42bf-b024-8235274a3b9e12013-04-01
49035-897-34ML - Milliliter49035-8973a654af5-ed3f-4fbf-a6db-e6790a91a77412015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMEQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
IBUPROFENACTIVE MOIETYWK2XYI10QMEQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GEQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAEQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HEQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
SORBITOLINACTIVE INGREDIENT506T60A25REQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
WATERINACTIVE INGREDIENT059QF0KO0REQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEEQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-897EQUATE IBUPROFEN (IBUPROFEN) SUSPENSION [WAL-MART STORES INC]5Current NDC, Legacy NDC, 4 package rows20250305_2daee8c1-d05e-406b-af65-b81bbbaa244d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN2daee8c1-d05e-406b-af65-b81bbbaa244d5
197803ibuprofen 20 MG/ML Oral SuspensionSCD2daee8c1-d05e-406b-af65-b81bbbaa244d5
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY2daee8c1-d05e-406b-af65-b81bbbaa244d5
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY2daee8c1-d05e-406b-af65-b81bbbaa244d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-897-26490350897261 BOTTLE in 1 CARTON (49035-897-26) / 118 mL in 1 BOTTLE1 bottle1999-02-020000-00-00NoNoCurrent
49035-897-34490350897341 BOTTLE in 1 CARTON (49035-897-34) / 237 mL in 1 BOTTLE1 bottle2010-12-160000-00-00NoNoCurrent