FDA.reportPublic FDA data

Ibuprofen

Product NDC
71205-522
11-digit product format
712050522
Labeler code
71205
Product ID
71205-522_89d2987c-469d-416c-b81b-70a3fff64427
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078329
Marketing category
ANDA
Marketing start
2018-08-24
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
71205-522-20Ibuprofen20 in 1 BOTTLETABLET, FILM COATED204
71205-522-28Ibuprofen28 in 1 BOTTLETABLET, FILM COATED284
71205-522-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED304
71205-522-42Ibuprofen42 in 1 BOTTLETABLET, FILM COATED424
71205-522-60Ibuprofen60 in 1 BOTTLETABLET, FILM COATED604
71205-522-90Ibuprofen90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-522-20EA - Each71205-522bbffa17f-1583-44a0-8656-20c1e074590512024-08-12
71205-522-28EA - Each71205-52239f29f30-3b04-4ef9-98dc-86062920b75d12021-02-05
71205-522-30EA - Each71205-5225b83ccae-ec54-4908-a297-4ddf0373901d12021-02-05
71205-522-60EA - Each71205-5221b30d6b5-7f2d-413c-a115-15cf7cba4b9612025-08-11
71205-522-90EA - Each71205-52293051ed0-3b2e-445c-bf5d-4d8928dbdd5812025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-522IBUPROFEN TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20250523_c5eaa3a9-5aa8-46b0-8cec-639bfb327475.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNc5eaa3a9-5aa8-46b0-8cec-639bfb3274754
197806ibuprofen 600 MG Oral TabletSCDc5eaa3a9-5aa8-46b0-8cec-639bfb3274754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-522-06712050522066 TABLET, FILM COATED in 1 BOTTLE (71205-522-06) 2021-01-070000-00-00NoNoCurrent
71205-522-157120505221515 TABLET, FILM COATED in 1 BOTTLE (71205-522-15) 2021-01-070000-00-00NoNoCurrent
71205-522-207120505222020 TABLET, FILM COATED in 1 BOTTLE (71205-522-20) 2021-01-070000-00-00NoNoCurrent
71205-522-287120505222828 TABLET, FILM COATED in 1 BOTTLE (71205-522-28) 2021-01-070000-00-00NoNoCurrent
71205-522-307120505223030 TABLET, FILM COATED in 1 BOTTLE (71205-522-30) 2021-01-070000-00-00NoNoCurrent
71205-522-407120505224040 TABLET, FILM COATED in 1 BOTTLE (71205-522-40) 2021-01-070000-00-00NoNoCurrent
71205-522-427120505224242 TABLET, FILM COATED in 1 BOTTLE (71205-522-42) 2024-08-010000-00-00NoNoCurrent
71205-522-607120505226060 TABLET, FILM COATED in 1 BOTTLE (71205-522-60) 2025-05-190000-00-00NoNoCurrent
71205-522-907120505229090 TABLET, FILM COATED in 1 BOTTLE (71205-522-90) 2025-05-190000-00-00NoNoCurrent