FDA.reportPublic FDA data

Ibuprofen

Product NDC
68788-8757
11-digit product format
687888757
Labeler code
68788
Product ID
68788-8757_c300eff8-05c9-4eaf-9de8-16d02e44eb2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202413
Marketing category
ANDA
Marketing start
2024-10-17
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibuprofen
Listing expiration
2027-12-31

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
68788-8757-1Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1002
68788-8757-2Ibuprofen20 in 1 BOTTLETABLET, FILM COATED202
68788-8757-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED302
68788-8757-4Ibuprofen14 in 1 BOTTLETABLET, FILM COATED142
68788-8757-5Ibuprofen50 in 1 BOTTLETABLET, FILM COATED502
68788-8757-6Ibuprofen60 in 1 BOTTLETABLET, FILM COATED602
68788-8757-7Ibuprofen21 in 1 BOTTLETABLET, FILM COATED212
68788-8757-8Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1202
68788-8757-9Ibuprofen90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8757-1EA - Each68788-87577af27744-ba21-4787-abc8-a77b525a5df812025-01-14
68788-8757-2EA - Each68788-875710ba1ef3-0e87-481d-bad8-ab85f68ea87a12025-01-14
68788-8757-3EA - Each68788-87579c819978-1cd2-476c-abd0-e06a1a6e5ac412025-01-14
68788-8757-4EA - Each68788-87576dd19a21-015d-4f46-912c-3fabfe5b0c7e12025-01-14
68788-8757-5EA - Each68788-8757bc9cc155-4c88-41ee-8d9b-60d1dfedb83512025-01-14
68788-8757-6EA - Each68788-875761f119c3-007f-4057-a34e-3a793bb5908c12025-01-14
68788-8757-7EA - Each68788-8757fac81f84-f707-4763-9619-36fee2778b3a12025-01-14
68788-8757-8EA - Each68788-87572313c509-2442-4ae9-af4a-0c7c2e86aa8912025-01-14
68788-8757-9EA - Each68788-87575fc08f1e-a489-4485-97f0-8b1bee1cff6112025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8757IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 9 package rows20241019_b84ea215-e61d-4c00-8a34-d47c4080779b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSNb84ea215-e61d-4c00-8a34-d47c4080779b2
197807ibuprofen 800 MG Oral TabletSCDb84ea215-e61d-4c00-8a34-d47c4080779b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8757-168788875701100 TABLET, FILM COATED in 1 BOTTLE (68788-8757-1) 2024-10-17NoNoHistorical
68788-8757-26878887570220 TABLET, FILM COATED in 1 BOTTLE (68788-8757-2) 2024-10-17NoNoHistorical
68788-8757-36878887570330 TABLET, FILM COATED in 1 BOTTLE (68788-8757-3) 2024-10-17NoNoHistorical
68788-8757-46878887570414 TABLET, FILM COATED in 1 BOTTLE (68788-8757-4) 2024-10-17NoNoHistorical
68788-8757-56878887570550 TABLET, FILM COATED in 1 BOTTLE (68788-8757-5) 2024-10-17NoNoHistorical
68788-8757-66878887570660 TABLET, FILM COATED in 1 BOTTLE (68788-8757-6) 2024-10-17NoNoHistorical
68788-8757-76878887570721 TABLET, FILM COATED in 1 BOTTLE (68788-8757-7) 2024-10-17NoNoHistorical
68788-8757-868788875708120 TABLET, FILM COATED in 1 BOTTLE (68788-8757-8) 2024-10-17NoNoHistorical
68788-8757-96878887570990 TABLET, FILM COATED in 1 BOTTLE (68788-8757-9) 2024-10-17NoNoHistorical