FDA.reportPublic FDA data

Ibuprofen

Product NDC
65162-356
11-digit product format
651620356
Labeler code
65162
Product ID
65162-356_53da63da-f301-44dc-902c-2c288304929f
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA202300
Marketing category
ANDA
Marketing start
2013-03-29
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
Pain Reliever/Fever Reducer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310964

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
65162-356-02IbuprofenPain Reliever/Fever Reducer1 in 1 CARTONCAPSULE, LIQUID FILLED111
65162-356-02IbuprofenPain Reliever/Fever Reducer20 in 1 BOTTLECAPSULE, LIQUID FILLED2011
65162-356-11IbuprofenPain Reliever/Fever Reducer1000 in 1 BOTTLECAPSULE, LIQUID FILLED100011
65162-356-50IbuprofenPain Reliever/Fever Reducer500 in 1 BOTTLECAPSULE, LIQUID FILLED50011
65162-356-69IbuprofenPain Reliever/Fever Reducer80 in 1 BOTTLECAPSULE, LIQUID FILLED8011
65162-356-69IbuprofenPain Reliever/Fever Reducer1 in 1 CARTONCAPSULE, LIQUID FILLED111

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDIBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LIBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQIBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TIBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]2
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-356IBUPROFEN PAIN RELIEVER/FEVER REDUCER (IBUPROFEN) CAPSULE, LIQUID FILLED [AMNEAL PHARMACEUTICALS LLC]11Current NDC, Legacy NDC, 6 package rows20241027_877440fc-3afb-4123-a2e6-5cb48c74413c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN877440fc-3afb-4123-a2e6-5cb48c74413c11
310964ibuprofen 200 MG Oral CapsuleSCD877440fc-3afb-4123-a2e6-5cb48c74413c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-356-02651620356021 BOTTLE in 1 CARTON (65162-356-02) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2013-03-290000-00-00NoNoCurrent
65162-356-11651620356111000 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-11) 2013-03-290000-00-00NoNoCurrent
65162-356-5065162035650500 CAPSULE, LIQUID FILLED in 1 BOTTLE (65162-356-50) 2013-03-290000-00-00NoNoCurrent
65162-356-69651620356691 BOTTLE in 1 CARTON (65162-356-69) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2013-03-290000-00-00NoNoCurrent