IBU

Product NDC
71205-604
11-digit product format
712050604
Labeler code
71205
Product ID
71205-604_f49b4e82-120c-4012-b4b3-78c0f89ae8fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075682
Marketing category
ANDA
Marketing start
2008-11-20
Substance
IBUPROFEN
Active strength
400 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
IBU
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM

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
71205-604-15IBU15 in 1 BOTTLETABLET153
71205-604-20IBU20 in 1 BOTTLETABLET203
71205-604-21IBU21 in 1 BOTTLETABLET213
71205-604-30IBU30 in 1 BOTTLETABLET303
71205-604-40IBU40 in 1 BOTTLETABLET403
71205-604-60IBU60 in 1 BOTTLETABLET603
71205-604-90IBU90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-604IBU (IBUPROFEN) TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 7 package rows20230325_ea6f626d-cda3-46e2-9ac9-4e72204cb726.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-604-157120506041515 TABLET in 1 BOTTLE (71205-604-15) 15 tablet2021-09-270000-00-00NoNoCurrent
71205-604-207120506042020 TABLET in 1 BOTTLE (71205-604-20) 20 tablet2021-09-270000-00-00NoNoCurrent
71205-604-217120506042121 TABLET in 1 BOTTLE (71205-604-21) 21 tablet2021-09-270000-00-00NoNoCurrent
71205-604-307120506043030 TABLET in 1 BOTTLE (71205-604-30) 30 tablet2021-08-270000-00-00NoNoCurrent
71205-604-407120506044040 TABLET in 1 BOTTLE (71205-604-40) 40 tablet2021-09-270000-00-00NoNoCurrent
71205-604-607120506046060 TABLET in 1 BOTTLE (71205-604-60) 60 tablet2021-08-270000-00-00NoNoCurrent
71205-604-907120506049090 TABLET in 1 BOTTLE (71205-604-90) 90 tablet2021-08-270000-00-00NoNoCurrent