FDA.reportPublic FDA data

Ibuprofen

Product NDC
72789-363
11-digit product format
727890363
Labeler code
72789
Product ID
72789-363_2badd321-76d3-0b3a-e063-6394a90a5564
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA091625
Marketing category
ANDA
Marketing start
2015-12-21
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
72789-363-01Ibuprofen100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10018
72789-363-10Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1018
72789-363-15Ibuprofen15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1518
72789-363-20Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2018
72789-363-21Ibuprofen21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2118
72789-363-24Ibuprofen24 in 1 BOTTLE, PLASTICTABLET, FILM COATED2418
72789-363-30Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3018
72789-363-40Ibuprofen40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4018
72789-363-60Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6018
72789-363-90Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-363-01EA - Each72789-363f0ef473b-4a46-47ee-9ed0-a1dd5cfd8bd912024-01-04
72789-363-10EA - Each72789-363b5aea09f-6114-48a0-bf33-e81f6c33210c12024-01-04
72789-363-15EA - Each72789-36368b98ab2-ae12-4121-b8a0-588c5641bf2212024-01-04
72789-363-20EA - Each72789-363d836f40a-5090-4fb0-afd7-aa945dbba60312024-01-04
72789-363-21EA - Each72789-36381711ee3-9da2-4006-9573-3901a6403d8312024-03-12
72789-363-24EA - Each72789-3630079bd81-e9ad-4b58-8ad4-7b86150db63612024-01-04
72789-363-30EA - Each72789-363cf370568-9a9d-487c-8f29-c200e76f157612024-01-04
72789-363-40EA - Each72789-3632c9325e4-a160-4cc6-be4a-7c5714440bbc12024-01-04
72789-363-60EA - Each72789-363487f985c-9295-4eca-ae3b-2d29a09473bf12024-01-04
72789-363-90EA - Each72789-363b0a9d7d2-de91-4a95-af60-3eea8d4b4f6f12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-363IBUPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18Current NDC, 10 package rows20250116_d3a7ebef-f7ab-4b34-b62e-278a8deabf78.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSNd3a7ebef-f7ab-4b34-b62e-278a8deabf7818
197806ibuprofen 600 MG Oral TabletSCDd3a7ebef-f7ab-4b34-b62e-278a8deabf7818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-363-0172789036301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-363-01) 2023-11-27NoNoHistorical
72789-363-107278903631010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-363-10) 2023-11-10NoNoHistorical
72789-363-157278903631515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-363-15) 2023-11-28NoNoHistorical
72789-363-207278903632020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-363-20) 2023-11-14NoNoHistorical
72789-363-217278903632121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-363-21) 2023-12-27NoNoHistorical
72789-363-247278903632424 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-363-24) 2023-11-07NoNoHistorical
72789-363-307278903633030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-363-30) 2023-11-13NoNoHistorical
72789-363-407278903634040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-363-40) 2023-11-28NoNoHistorical
72789-363-607278903636060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-363-60) 2023-11-17NoNoHistorical
72789-363-907278903639090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-363-90) 2024-02-21NoNoHistorical