FDA.reportPublic FDA data

Ibuprofen

Product NDC
72789-200
11-digit product format
727890200
Labeler code
72789
Product ID
72789-200_3417f658-e09c-4667-e063-6394a90a7228
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
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
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
72789-200-10Ibuprofen10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1014
72789-200-12Ibuprofen12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1214
72789-200-15Ibuprofen15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1514
72789-200-20Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2014
72789-200-21Ibuprofen21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2114
72789-200-30Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3014
72789-200-40Ibuprofen40 in 1 BOTTLE, PLASTICTABLET, FILM COATED4014
72789-200-60Ibuprofen60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6014
72789-200-90Ibuprofen90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9014
72789-200-93Ibuprofen180 in 1 BOTTLE, PLASTICTABLET, FILM COATED18014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-200IBUPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]14Current NDC, Legacy NDC, 10 package rows20250503_689dbbe8-4f85-48fe-8efc-fda81b60d37f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN689dbbe8-4f85-48fe-8efc-fda81b60d37f14
197807ibuprofen 800 MG Oral TabletSCD689dbbe8-4f85-48fe-8efc-fda81b60d37f14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-200-107278902001010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-10) 2021-09-280000-00-00NoNoCurrent
72789-200-127278902001212 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-12) 2021-10-110000-00-00NoNoCurrent
72789-200-157278902001515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-15) 2021-09-210000-00-00NoNoCurrent
72789-200-207278902002020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-20) 2021-09-280000-00-00NoNoCurrent
72789-200-217278902002121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-21) 2021-09-280000-00-00NoNoCurrent
72789-200-307278902003030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-30) 2021-08-230000-00-00NoNoCurrent
72789-200-407278902004040 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-40) 2021-09-280000-00-00NoNoCurrent
72789-200-607278902006060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-60) 2021-08-230000-00-00NoNoCurrent
72789-200-907278902009090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-90) 2021-08-230000-00-00NoNoCurrent
72789-200-9372789020093180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-200-93) 2021-09-280000-00-00NoNoCurrent