FDA.reportPublic FDA data

Ibuprofen

Product NDC
71610-968
11-digit product format
716100968
Labeler code
71610
Product ID
71610-968_4b493718-4d0c-077c-e063-6394a90a66b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075682
Marketing category
ANDA
Marketing start
2025-09-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

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
71610-968-53Ibuprofen60 in 1 BOTTLETABLET602
71610-968-60Ibuprofen90 in 1 BOTTLETABLET902
71610-968-80Ibuprofen180 in 1 BOTTLETABLET1802
71610-968-92Ibuprofen270 in 1 BOTTLETABLET2702

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-968-60EA - Each71610-9682b43933f-757a-4b34-ac0b-69a89ea8089b12026-03-17
71610-968-80EA - Each71610-9689efd7c68-94b0-4f81-805a-789b7a533d6c12026-03-17
71610-968-92EA - Each71610-9681a7544b0-1e14-4ea9-9b0b-7532fd0e20d012026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN4522b794-5c93-44cd-e063-6394a90ab39a2
197806ibuprofen 600 MG Oral TabletSCD4522b794-5c93-44cd-e063-6394a90ab39a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71610-968-537161009685360 TABLET in 1 BOTTLE (71610-968-53) 60 tablet2026-02-20NoNoHistorical
71610-968-607161009686090 TABLET in 1 BOTTLE (71610-968-60) 90 tablet2025-12-03NoNoHistorical
71610-968-8071610096880180 TABLET in 1 BOTTLE (71610-968-80) 180 tablet2025-12-03NoNoHistorical
71610-968-9271610096892270 TABLET in 1 BOTTLE (71610-968-92) 270 tablet2025-12-03NoNoHistorical