FDA.reportPublic FDA data

Ibuprofen

Product NDC
82804-227
11-digit product format
828040227
Labeler code
82804
Product ID
82804-227_67101108-a41f-4be1-8160-6a817c4c301e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202413
Marketing category
ANDA
Marketing start
2024-05-23
Substance
IBUPROFEN
Active strength
800 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
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197807

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
82804-227-15Ibuprofen15 in 1 BOTTLETABLET, FILM COATED156
82804-227-20Ibuprofen20 in 1 BOTTLETABLET, FILM COATED206
82804-227-21Ibuprofen21 in 1 BOTTLETABLET, FILM COATED216
82804-227-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED306
82804-227-60Ibuprofen60 in 1 BOTTLETABLET, FILM COATED606
82804-227-90Ibuprofen90 in 1 BOTTLETABLET, FILM COATED906

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNab2f1a30-611b-41b6-9baf-6a82305da8456
197807ibuprofen 800 MG Oral TabletSCDab2f1a30-611b-41b6-9baf-6a82305da8456

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82804-227-158280402271515 TABLET, FILM COATED in 1 BOTTLE (82804-227-15) 2026-01-16NoNoCurrent
82804-227-208280402272020 TABLET, FILM COATED in 1 BOTTLE (82804-227-20) 2026-03-03NoNoCurrent
82804-227-218280402272121 TABLET, FILM COATED in 1 BOTTLE (82804-227-21) 2026-03-10NoNoCurrent
82804-227-308280402273030 TABLET, FILM COATED in 1 BOTTLE (82804-227-30) 2025-07-14NoNoCurrent
82804-227-608280402276060 TABLET, FILM COATED in 1 BOTTLE (82804-227-60) 2025-08-12NoNoCurrent
82804-227-908280402279090 TABLET, FILM COATED in 1 BOTTLE (82804-227-90) 2025-09-03NoNoCurrent