FDA.reportPublic FDA data

Ibuprofen

Product NDC
49035-693
11-digit product format
490350693
Labeler code
49035
Product ID
49035-693_3bb4a859-a353-e550-e063-6394a90a7645
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
EQUATE (WAL-MART STORES, INC.)
Application
ANDA209207
Marketing category
ANDA
Marketing start
2017-06-27
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-693-082025-08-06C16284748780-13b156c62-31f0-fb37-e063-e6dba90a4e07Ibuprofen
49035-693-092025-08-06C16284748780-13b156c62-31f0-fb37-e063-e6dba90a4e07Ibuprofen
49035-693-082025-07-29C16284748780-13b156c62-31f0-fb37-e063-e6dba90a4e07Ibuprofen
49035-693-092025-07-29C16284748780-13b156c62-31f0-fb37-e063-e6dba90a4e07Ibuprofen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-693-08Ibuprofen1 in 1 CARTONSUSPENSION13
49035-693-08Ibuprofen120 mL in 1 BOTTLESUSPENSION1203
49035-693-09Ibuprofen120 mL in 1 BOTTLESUSPENSION1203
49035-693-09Ibuprofen1 in 1 CARTONSUSPENSION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-693-09ML - Milliliter49035-693bb4f336a-150e-4b3b-9166-b3d8eaa568dc12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-693IBUPROFEN SUSPENSION [EQUATE (WAL-MART STORES, INC.)]2Current NDC, Legacy NDC, 4 package rows20210417_104b5ac1-9c5e-40f8-a9b1-1761b495bb1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197803ibuprofen 100 MG in 5 mL Oral SuspensionPSN104b5ac1-9c5e-40f8-a9b1-1761b495bb1c3
197803ibuprofen 20 MG/ML Oral SuspensionSCD104b5ac1-9c5e-40f8-a9b1-1761b495bb1c3
197803ibuprofen 100 MG per 5 ML Oral SuspensionSY104b5ac1-9c5e-40f8-a9b1-1761b495bb1c3
197803ibuprofen 200 MG per 10 ML Oral SuspensionSY104b5ac1-9c5e-40f8-a9b1-1761b495bb1c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-693-08490350693081 BOTTLE in 1 CARTON (49035-693-08) / 120 mL in 1 BOTTLE1 bottle2019-02-140000-00-00NoNoCurrent
49035-693-09490350693091 BOTTLE in 1 CARTON (49035-693-09) / 120 mL in 1 BOTTLE1 bottle2021-03-040000-00-00NoNoCurrent