FDA.reportPublic FDA data

Ibuprofen

Product NDC
59556-855
11-digit product format
595560855
Labeler code
59556
Product ID
59556-855_1f4159ad-d58c-4519-932b-030cc2735514
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Strides Pharma Inc.
Application
ANDA091355
Marketing category
ANDA
Marketing start
2011-04-04
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
Immediate Release
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
59556-855-42IbuprofenImmediate Release10000 in 1 BAGTABLET, COATED100003
59556-855-06IbuprofenImmediate Release1 in 1 CARTONTABLET, COATED11
59556-855-06IbuprofenImmediate Release100 in 1 BOTTLETABLET, COATED1001
59556-855-07IbuprofenImmediate Release1 in 1 CARTONTABLET, COATED11
59556-855-07IbuprofenImmediate Release500 in 1 BOTTLETABLET, COATED5001
59556-855-08IbuprofenImmediate Release1000 in 1 BOTTLETABLET, COATED10001
59556-855-08IbuprofenImmediate Release1 in 1 CARTONTABLET, COATED11
59556-855-25IbuprofenImmediate Release1 in 1 CARTONTABLET, COATED11
59556-855-25IbuprofenImmediate Release50 in 1 BOTTLETABLET, COATED501
59556-855-41IbuprofenImmediate Release24 in 1 BOTTLETABLET, COATED241
59556-855-41IbuprofenImmediate Release1 in 1 CARTONTABLET, COATED11
59556-855-44IbuprofenImmediate Release1 in 1 CARTONTABLET, COATED11
59556-855-44IbuprofenImmediate Release165 in 1 BOTTLETABLET, COATED1651
59556-855-46IbuprofenImmediate Release1000 in 1 BAGTABLET, COATED10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59556-855IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC]3Current NDC, Legacy NDC, 1 package rows20240523_ebcc4da3-d0f6-4e40-99b5-e88310ea4a5b.zip
59556-855IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC.]1Current NDC, Legacy NDC, 13 package rows20170601_1f4159ad-d58c-4519-932b-030cc2735514.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNebcc4da3-d0f6-4e40-99b5-e88310ea4a5b3
310965ibuprofen 200 MG Oral TabletSCDebcc4da3-d0f6-4e40-99b5-e88310ea4a5b3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYebcc4da3-d0f6-4e40-99b5-e88310ea4a5b3
310965ibuprofen 200 MG Oral TabletPSN1f4159ad-d58c-4519-932b-030cc27355141
310965ibuprofen 200 MG Oral TabletSCD1f4159ad-d58c-4519-932b-030cc27355141
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY1f4159ad-d58c-4519-932b-030cc27355141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59556-855-06595560855061 BOTTLE in 1 CARTON (59556-855-06) / 100 TABLET, COATED in 1 BOTTLE1 bottle2011-04-040000-00-00NoNoCurrent
59556-855-07595560855071 BOTTLE in 1 CARTON (59556-855-07) / 500 TABLET, COATED in 1 BOTTLE1 bottle2011-04-040000-00-00NoNoCurrent
59556-855-08595560855081 BOTTLE in 1 CARTON (59556-855-08) / 1000 TABLET, COATED in 1 BOTTLE1 bottle2011-04-040000-00-00NoNoCurrent
59556-855-25595560855251 BOTTLE in 1 CARTON (59556-855-25) / 50 TABLET, COATED in 1 BOTTLE1 bottle2011-04-040000-00-00NoNoCurrent
59556-855-41595560855411 BOTTLE in 1 CARTON (59556-855-41) / 24 TABLET, COATED in 1 BOTTLE1 bottle2011-04-040000-00-00NoNoCurrent
59556-855-425955608554210000 TABLET, COATED in 1 BAG (59556-855-42) 2022-03-180000-00-00NoNoCurrent
59556-855-44595560855441 BOTTLE in 1 CARTON (59556-855-44) / 165 TABLET, COATED in 1 BOTTLE1 bottle2011-04-040000-00-00NoNoCurrent
59556-855-46595560855461000 TABLET, COATED in 1 BAG (59556-855-46) 2011-04-040000-00-00NoNoCurrent