FDA.reportPublic FDA data

Ibuprofen

Product NDC
37835-581
11-digit product format
378350581
Labeler code
37835
Product ID
37835-581_2eb89807-b8b2-e482-e063-6294a90aea80
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Bi-Mart
Application
ANDA079174
Marketing category
ANDA
Marketing start
2011-01-01
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
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
37835-581-01Ibuprofen100 in 1 BOTTLETABLET1001
37835-581-05Ibuprofen500 in 1 BOTTLETABLET5001
37835-581-10Ibuprofen1000 in 1 BOTTLETABLET10001
37835-581-25Ibuprofen250 in 1 BOTTLETABLET2501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37835-581IBUPROFEN TABLET [BI-MART]1Current NDC, 4 package rows20250226_7ceacd63-d5fa-4cab-b8f3-a5131c97bb90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN7ceacd63-d5fa-4cab-b8f3-a5131c97bb901
310965ibuprofen 200 MG Oral TabletSCD7ceacd63-d5fa-4cab-b8f3-a5131c97bb901
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY7ceacd63-d5fa-4cab-b8f3-a5131c97bb901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37835-581-0137835058101100 TABLET in 1 BOTTLE (37835-581-01) 100 tablet2025-02-01NoNoCurrent
37835-581-0537835058105500 TABLET in 1 BOTTLE (37835-581-05) 500 tablet2025-02-01NoNoCurrent
37835-581-10378350581101000 TABLET in 1 BOTTLE (37835-581-10) 1000 tablet2025-02-01NoNoCurrent
37835-581-2537835058125250 TABLET in 1 BOTTLE (37835-581-25) 250 tablet2025-02-01NoNoCurrent