FDA.reportPublic FDA data

ibuprofen

Product NDC
72789-191
11-digit product format
727890191
Labeler code
72789
Product ID
72789-191_460208a0-114d-960f-e063-6294a90a0981
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA072096
Marketing category
ANDA
Marketing start
2018-09-20
Substance
IBUPROFEN
Active strength
200 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
IBUPROFEN200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui310965

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
72789-191-20ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2010
72789-191-21ibuprofen21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2110
72789-191-30ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-191-20EA - Each72789-191df63a82b-99da-41c5-a844-17e8b04b644912023-06-06
72789-191-21EA - Each72789-191f0e544a4-b9bd-4c58-a5f8-a8f89671dc8112026-01-08
72789-191-30EA - Each72789-19145bc31cb-5fe1-4fd4-abe4-0764c547aad912022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-191IBUPROFEN TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 3 package rows20250503_96bff700-bca3-4b94-b8a2-379102721db8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN96bff700-bca3-4b94-b8a2-379102721db810
310965ibuprofen 200 MG Oral TabletSCD96bff700-bca3-4b94-b8a2-379102721db810
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY96bff700-bca3-4b94-b8a2-379102721db810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72789-191-207278901912020 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-20) 2023-05-09NoNoHistorical
72789-191-217278901912121 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-21) 2025-12-15NoNoHistorical
72789-191-307278901913030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-191-30) 2021-06-010000-00-00NoNoCurrent