FDA.reportPublic FDA data

IBUPROFEN

Product NDC
59556-857
11-digit product format
595560857
Labeler code
59556
Product ID
59556-857_31a2c138-64f4-4ce0-ab02-d227240737dd
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Strides Pharma Inc
Application
ANDA079129
Marketing category
ANDA
Marketing start
2022-03-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IBUPROFEN
Brand name suffix
Immediate Release
Listing expiration
2027-12-31

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
59556-857-42IBUPROFENImmediate Release10000 in 1 BAGTABLET, COATED100006
59556-857-43IBUPROFENImmediate Release30000 in 1 BAGTABLET, COATED300006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59556-857IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [STRIDES PHARMA INC]4Current NDC, Legacy NDC, 2 package rows20240523_a5dd275f-f388-44ec-8297-74430a742d52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNda16b1a9-0db2-4f2f-bc85-05ea5ab26e1c8
310965ibuprofen 200 MG Oral TabletSCDda16b1a9-0db2-4f2f-bc85-05ea5ab26e1c8
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYda16b1a9-0db2-4f2f-bc85-05ea5ab26e1c8
310965ibuprofen 200 MG Oral TabletPSNa5dd275f-f388-44ec-8297-74430a742d526
310965ibuprofen 200 MG Oral TabletSCDa5dd275f-f388-44ec-8297-74430a742d526
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYa5dd275f-f388-44ec-8297-74430a742d526
310965ibuprofen 200 MG Oral TabletPSN6d1c9a64-c83c-4b3d-9245-704b94cb367c3
310965ibuprofen 200 MG Oral TabletSCD6d1c9a64-c83c-4b3d-9245-704b94cb367c3
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY6d1c9a64-c83c-4b3d-9245-704b94cb367c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59556-857-425955608574210000 TABLET, COATED in 1 BAG (59556-857-42) 2022-03-180000-00-00NoNoCurrent
59556-857-435955608574330000 TABLET, COATED in 1 BAG (59556-857-43) 2023-06-01NoNoHistorical