FDA.reportPublic FDA data

Ibuprofen

Product NDC
25000-062
11-digit product format
250000062
Labeler code
25000
Product ID
25000-062_009afd24-3f12-4208-876d-f22ce92a40ce
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
MARKSANS PHARMA LIMITED
Application
ANDA079205
Marketing category
ANDA
Marketing start
2020-08-18
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
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
25000-062-01Ibuprofen20 in 1 BOTTLECAPSULE, LIQUID FILLED2011
25000-062-01Ibuprofen01 in 1 CARTONCAPSULE, LIQUID FILLED0111
25000-062-04Ibuprofen32 in 1 BOTTLECAPSULE, LIQUID FILLED3211
25000-062-04Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED111
25000-062-13Ibuprofen600 in 1 BOTTLECAPSULE, LIQUID FILLED60011
25000-062-43Ibuprofen10 in 1 BOTTLECAPSULE, LIQUID FILLED1011
25000-062-43Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED111
25000-062-67Ibuprofen80 in 1 BOTTLECAPSULE, LIQUID FILLED8011
25000-062-67Ibuprofen1 in 1 CARTONCAPSULE, LIQUID FILLED111
25000-062-69Ibuprofen300 in 1 BOTTLECAPSULE, LIQUID FILLED30011
25000-062-87Ibuprofen1 in 1 BOXCAPSULE, LIQUID FILLED111
25000-062-87Ibuprofen2500 in 1 BAGCAPSULE, LIQUID FILLED250011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XIBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SIBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3
GELATININACTIVE INGREDIENT2G86QN327LIBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3
SHELLACINACTIVE INGREDIENT46N107B71OIBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56IBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25000-062IBUPROFEN CAPSULE, LIQUID FILLED [MARKSANS PHARMA LIMITED]11Current NDC, Legacy NDC, 12 package rows20230406_403ec259-3be1-4e0b-ab7b-fee213b7eabe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN403ec259-3be1-4e0b-ab7b-fee213b7eabe11
310964ibuprofen 200 MG Oral CapsuleSCD403ec259-3be1-4e0b-ab7b-fee213b7eabe11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25000-062-01250000062011 BOTTLE in 1 CARTON (25000-062-01) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-08-180000-00-00NoNoCurrent
25000-062-04250000062041 BOTTLE in 1 CARTON (25000-062-04) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-08-180000-00-00NoNoCurrent
25000-062-1325000006213600 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-062-13) 2020-08-180000-00-00NoNoCurrent
25000-062-43250000062431 BOTTLE in 1 CARTON (25000-062-43) / 10 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-08-180000-00-00NoNoCurrent
25000-062-67250000062671 BOTTLE in 1 CARTON (25000-062-67) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-08-180000-00-00NoNoCurrent
25000-062-6925000006269300 CAPSULE, LIQUID FILLED in 1 BOTTLE (25000-062-69) 2021-11-250000-00-00NoNoCurrent
25000-062-87250000062871 BAG in 1 BOX (25000-062-87) / 2500 CAPSULE, LIQUID FILLED in 1 BAG1 bag2020-08-180000-00-00NoNoCurrent