FDA.reportPublic FDA data

Ibuprofen

Product NDC
72789-364
11-digit product format
727890364
Labeler code
72789
Product ID
72789-364_2bae0294-44aa-33ff-e063-6294a90a8386
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
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
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
72789-364-06Ibuprofen6 in 1 BOTTLE, PLASTICTABLET, FILM COATED618
72789-364-10Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1018
72789-364-15Ibuprofen15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1518
72789-364-20Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2018
72789-364-21Ibuprofen21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2118
72789-364-30Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3018
72789-364-40Ibuprofen40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4018
72789-364-60Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6018
72789-364-90Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9018
72789-364-93Ibuprofen180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-364-06EA - Each72789-3649d91d07a-45cb-4c7e-9ae1-807ec00d877d12024-05-16
72789-364-10EA - Each72789-364a1adada4-7a8a-4351-bca5-2a2dbd78f57712024-01-04
72789-364-15EA - Each72789-364e861e058-7347-4b23-84ab-ff6250366a8b12024-02-14
72789-364-20EA - Each72789-3647a52ddb2-45a7-49f8-b8ce-91f48d49c18e12024-02-14
72789-364-21EA - Each72789-364a9c6d1d9-0000-4659-878c-916c7288b97612024-03-12
72789-364-30EA - Each72789-364323e176a-04ff-45e3-98aa-3e033ebeb0d312024-01-04
72789-364-40EA - Each72789-364fddcb31c-b837-4ed5-8240-943212b956a912024-01-04
72789-364-60EA - Each72789-364b96f605d-ab41-4bb8-82c2-3a7e7d32e5a912024-01-04
72789-364-90EA - Each72789-36403cb5b18-b701-497a-8c79-061752bf6f0112024-03-12
72789-364-93EA - Each72789-3649774e9f9-d4b8-49e4-838b-725c5c057fb812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-364IBUPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18Current NDC, 10 package rows20250116_0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d818
197807ibuprofen 800 MG Oral TabletSCD0cb73c19-a7cb-4ad9-9aa5-c24afb80d6d818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-364-06727890364066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-06) 2024-03-15NoNoCurrent
72789-364-107278903641010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-10) 2023-11-13NoNoCurrent
72789-364-157278903641515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-15) 2023-12-11NoNoCurrent
72789-364-207278903642020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-20) 2023-12-11NoNoCurrent
72789-364-217278903642121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-21) 2024-01-11NoNoCurrent
72789-364-307278903643030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-30) 2023-11-14NoNoCurrent
72789-364-407278903644040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-40) 2023-11-15NoNoCurrent
72789-364-607278903646060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-60) 2023-11-13NoNoCurrent
72789-364-907278903649090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-90) 2024-01-24NoNoCurrent
72789-364-9372789036493180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-364-93) 2023-12-12NoNoCurrent