Ibuprofen

Product NDC
72789-201
11-digit product format
727890201
Labeler code
72789
Product ID
72789-201_34180aa0-9db5-4fc8-e063-6394a90ab864
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
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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
72789-201-06Ibuprofen6 in 1 BOTTLE, PLASTICTABLET, FILM COATED612
72789-201-20Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2012
72789-201-40Ibuprofen40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-201-06EA - Each72789-201045ff22e-1d47-4a3d-8ede-75c9402e094e12022-01-06
72789-201-20EA - Each72789-2017d3393fb-dd7f-4a92-a98d-486debfca90e12021-09-07
72789-201-40EA - Each72789-20150c7887c-8c40-4121-86a1-f488ea5e199712023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-201IBUPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]12Current NDC, Legacy NDC, 3 package rows20250503_42b92fd7-468c-4fb8-9ff0-31296735df4c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN42b92fd7-468c-4fb8-9ff0-31296735df4c12
197805ibuprofen 400 MG Oral TabletSCD42b92fd7-468c-4fb8-9ff0-31296735df4c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-201-06727890201066 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-06) 2021-12-150000-00-00NoNoCurrent
72789-201-207278902012020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-20) 2021-08-240000-00-00NoNoCurrent
72789-201-407278902014040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-201-40) 2023-03-15NoNoCurrent