FDA.reportPublic FDA data

Ibuprofen

Product NDC
72789-186
11-digit product format
727890186
Labeler code
72789
Product ID
72789-186_34178401-0edc-512f-e063-6294a90ab88a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078329
Marketing category
ANDA
Marketing start
2020-08-21
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
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
IBUPROFEN800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805, 197806, 197807

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
72789-186-30Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3015
72789-186-60Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6015
72789-186-82Ibuprofen500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50015
72789-186-90Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-186IBUPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 4 package rows20250503_3732defa-67c2-4b84-8a84-4bbc27b6cb24.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN3732defa-67c2-4b84-8a84-4bbc27b6cb2415
197806ibuprofen 600 MG Oral TabletPSN3732defa-67c2-4b84-8a84-4bbc27b6cb2415
197807ibuprofen 800 MG Oral TabletPSN3732defa-67c2-4b84-8a84-4bbc27b6cb2415
197805ibuprofen 400 MG Oral TabletSCD3732defa-67c2-4b84-8a84-4bbc27b6cb2415
197806ibuprofen 600 MG Oral TabletSCD3732defa-67c2-4b84-8a84-4bbc27b6cb2415
197807ibuprofen 800 MG Oral TabletSCD3732defa-67c2-4b84-8a84-4bbc27b6cb2415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-186-307278901863030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-186-30) 2021-05-180000-00-00NoNoCurrent
72789-186-607278901866060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-186-60) 2021-05-180000-00-00NoNoCurrent
72789-186-8272789018682500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-186-82) 2021-05-110000-00-00NoNoCurrent
72789-186-907278901869090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-186-90) 2021-05-180000-00-00NoNoCurrent