FDA.reportPublic FDA data

Ibuprofen

Product NDC
72789-565
11-digit product format
727890565
Labeler code
72789
Product ID
72789-565_5012abfc-f095-ec40-e063-6394a90a283a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA202413
Marketing category
ANDA
Marketing start
2025-12-15
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
72789-565-30Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3021
72789-565-60Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6021
72789-565-82Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50021
72789-565-86Ibuprofen360 in 1 BOTTLE, PLASTICTABLET, FILM COATED36021
72789-565-90Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9021
72789-565-93Ibuprofen180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18021
72789-565-94Ibuprofen270 in 1 BOTTLE, PLASTICTABLET, FILM COATED27021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN3a38add6-a114-4e18-836c-3bfc727db23121
197807ibuprofen 800 MG Oral TabletSCD3a38add6-a114-4e18-836c-3bfc727db23121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-565-307278905653030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-30) 2026-04-16NoNoCurrent
72789-565-607278905656060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-60) 2026-04-16NoNoCurrent
72789-565-8272789056582500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-82) 2026-04-16NoNoCurrent
72789-565-8672789056586360 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-86) 2026-04-16NoNoCurrent
72789-565-907278905659090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-90) 2026-04-16NoNoCurrent
72789-565-9372789056593180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-93) 2026-04-16NoNoCurrent
72789-565-9472789056594270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-565-94) 2026-04-16NoNoCurrent