Ibuprofen

Product NDC
69168-335
11-digit product format
691680335
Labeler code
69168
Product ID
69168-335_efd20a4b-fd12-46e4-ad80-5065264a4203
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen 200 mg
Dosage form
TABLET
Route
ORAL
Labeler
Allegiant Health
Application
ANDA079129
Marketing category
ANDA
Marketing start
2014-12-19
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
Brand name suffix
Fast relief medicine for pain
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
69168-335-01IbuprofenFast relief medicine for pain100 in 1 BOXTABLET1007
69168-335-03IbuprofenFast relief medicine for pain250 in 1 BOTTLETABLET2507
69168-335-30IbuprofenFast relief medicine for pain30 in 1 BOXTABLET307
69168-335-40IbuprofenFast relief medicine for pain40 in 1 BOXTABLET407

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-335IBUPROFEN FAST RELIEF MEDICINE FOR PAIN (IBUPROFEN 200 MG) TABLET [ALLEGIANT HEALTH]7Current NDC, Legacy NDC, 4 package rows20190103_dd63b011-0573-4374-9669-8d29146e5fc9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNdd63b011-0573-4374-9669-8d29146e5fc97
310965ibuprofen 200 MG Oral TabletSCDdd63b011-0573-4374-9669-8d29146e5fc97
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYdd63b011-0573-4374-9669-8d29146e5fc97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69168-335-0169168033501100 TABLET in 1 BOX (69168-335-01) 100 tablet2014-12-190000-00-00NoNoCurrent
69168-335-0369168033503250 TABLET in 1 BOTTLE (69168-335-03) 250 tablet2014-12-190000-00-00NoNoCurrent
69168-335-306916803353030 TABLET in 1 BOX (69168-335-30) 30 tablet2014-12-190000-00-00NoNoCurrent
69168-335-406916803354040 TABLET in 1 BOX (69168-335-40) 40 tablet2014-12-190000-00-00NoNoCurrent