FDA.reportPublic FDA data

Ibuprofen

Product NDC
71610-222
11-digit product format
716100222
Labeler code
71610
Product ID
71610-222_d7886733-60dc-49ae-9147-240efccc08bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
Substance
IBUPROFEN
Active strength
600 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
IBUPROFEN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197806

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
71610-222-60Ibuprofen90 in 1 BOTTLETABLET, FILM COATED901
71610-222-80Ibuprofen180 in 1 BOTTLETABLET, FILM COATED1801
71610-222-92Ibuprofen270 in 1 BOTTLETABLET, FILM COATED2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-222-60EA - Each71610-222bf4c0a5b-76f2-4522-bb02-6ad02501274a12019-02-13
71610-222-80EA - Each71610-222d83bb2bf-7471-4075-ad8d-67b6a89d8c5912019-02-13
71610-222-92EA - Each71610-222666a728c-233e-475a-9811-0cca11dcafd112019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-222IBUPROFEN TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20190122_4a86a190-da5d-4b7a-a05f-e3e7ccbfa603.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN4a86a190-da5d-4b7a-a05f-e3e7ccbfa6031
197806ibuprofen 600 MG Oral TabletSCD4a86a190-da5d-4b7a-a05f-e3e7ccbfa6031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-222-607161002226090 TABLET, FILM COATED in 1 BOTTLE (71610-222-60) 2019-01-140000-00-00NoNoCurrent
71610-222-8071610022280180 TABLET, FILM COATED in 1 BOTTLE (71610-222-80) 2019-01-140000-00-00NoNoCurrent
71610-222-9271610022292270 TABLET, FILM COATED in 1 BOTTLE (71610-222-92) 2019-01-140000-00-00NoNoCurrent