FDA.reportPublic FDA data

ibuprofen

Product NDC
37808-604
11-digit product format
378080604
Labeler code
37808
Product ID
37808-604_4ad740c1-e87a-4ade-87b5-d00ab47f2af5
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H E B
Application
ANDA072096
Marketing category
ANDA
Marketing start
1989-02-15
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
37808-604-62ibuprofen1 in 1 CARTONTABLET, FILM COATED15
37808-604-62ibuprofen24 in 1 BOTTLETABLET, FILM COATED245
37808-604-71ibuprofen50 in 1 BOTTLETABLET, FILM COATED505
37808-604-71ibuprofen1 in 1 CARTONTABLET, FILM COATED15
37808-604-78ibuprofen1 in 1 CARTONTABLET, FILM COATED15
37808-604-78ibuprofen100 in 1 BOTTLETABLET, FILM COATED1005
37808-604-85ibuprofen250 in 1 BOTTLETABLET, FILM COATED2505

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET, FILM COATED [H E B]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET, FILM COATED [H E B]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET, FILM COATED [H E B]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET, FILM COATED [H E B]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET, FILM COATED [H E B]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET, FILM COATED [H E B]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBUPROFEN TABLET, FILM COATED [H E B]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET, FILM COATED [H E B]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET, FILM COATED [H E B]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN TABLET, FILM COATED [H E B]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET, FILM COATED [H E B]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET, FILM COATED [H E B]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET, FILM COATED [H E B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-604IBUPROFEN TABLET, FILM COATED [H E B]5Current NDC, Legacy NDC, 7 package rows20241204_a340ed68-debb-4c1e-97eb-82f6e9e3854f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNa340ed68-debb-4c1e-97eb-82f6e9e3854f5
310965ibuprofen 200 MG Oral TabletSCDa340ed68-debb-4c1e-97eb-82f6e9e3854f5
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYa340ed68-debb-4c1e-97eb-82f6e9e3854f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-604-62378080604621 BOTTLE in 1 CARTON (37808-604-62) > 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2000-01-050000-00-00NoNoCurrent
37808-604-71378080604711 BOTTLE in 1 CARTON (37808-604-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1989-02-150000-00-00NoNoCurrent
37808-604-78378080604781 BOTTLE in 1 CARTON (37808-604-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1994-09-230000-00-00NoNoCurrent
37808-604-8537808060485250 TABLET, FILM COATED in 1 BOTTLE (37808-604-85) 1993-01-060000-00-00NoNoCurrent