FDA.reportPublic FDA data

Ibuprofen

Product NDC
68788-8754
11-digit product format
687888754
Labeler code
68788
Product ID
68788-8754_60c0958f-f255-410c-ba26-3b819475064c
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
2024-10-14
Substance
IBUPROFEN
Active strength
600 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
IBUPROFEN600 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197806

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
68788-8754-1Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1002
68788-8754-2Ibuprofen20 in 1 BOTTLETABLET, FILM COATED202
68788-8754-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED302
68788-8754-4Ibuprofen14 in 1 BOTTLETABLET, FILM COATED142
68788-8754-5Ibuprofen50 in 1 BOTTLETABLET, FILM COATED502
68788-8754-6Ibuprofen60 in 1 BOTTLETABLET, FILM COATED602
68788-8754-7Ibuprofen21 in 1 BOTTLETABLET, FILM COATED212
68788-8754-8Ibuprofen120 in 1 BOTTLETABLET, FILM COATED1202
68788-8754-9Ibuprofen90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8754-1EA - Each68788-87544a6b8ca7-c12e-4397-b2d0-d40e9cb7a4ca12024-12-10
68788-8754-2EA - Each68788-8754b74edead-f5cf-4439-97f1-8f899436814f12024-12-10
68788-8754-3EA - Each68788-8754e8a198db-1904-4dda-b7ef-1771195fa1eb12024-12-10
68788-8754-4EA - Each68788-8754ef890aba-a55a-45fa-9809-fedfe2c0faf412024-12-10
68788-8754-5EA - Each68788-8754fcabcdb4-b4b5-42b8-a7b8-37bc14e67b0e12024-12-10
68788-8754-6EA - Each68788-8754141f4bf5-848c-4942-b199-0608a92ba70412024-12-10
68788-8754-7EA - Each68788-8754dc1622e4-c794-45a1-abe4-d7bc5bc4b29612024-12-10
68788-8754-8EA - Each68788-87541ef84673-0b23-4817-aaa5-5430f0ce88bd12024-12-10
68788-8754-9EA - Each68788-87543c1d9f78-fa29-470e-9855-0769fd83cb5512024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8754IBUPROFEN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 9 package rows20241016_70e191ef-8fad-49eb-9850-fceea119e92f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197806ibuprofen 600 MG Oral TabletPSN70e191ef-8fad-49eb-9850-fceea119e92f2
197806ibuprofen 600 MG Oral TabletSCD70e191ef-8fad-49eb-9850-fceea119e92f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8754-168788875401100 TABLET, FILM COATED in 1 BOTTLE (68788-8754-1) 2024-10-14NoNoHistorical
68788-8754-26878887540220 TABLET, FILM COATED in 1 BOTTLE (68788-8754-2) 2024-10-14NoNoHistorical
68788-8754-36878887540330 TABLET, FILM COATED in 1 BOTTLE (68788-8754-3) 2024-10-14NoNoHistorical
68788-8754-46878887540414 TABLET, FILM COATED in 1 BOTTLE (68788-8754-4) 2024-10-14NoNoHistorical
68788-8754-56878887540550 TABLET, FILM COATED in 1 BOTTLE (68788-8754-5) 2024-10-14NoNoHistorical
68788-8754-66878887540660 TABLET, FILM COATED in 1 BOTTLE (68788-8754-6) 2024-10-14NoNoHistorical
68788-8754-76878887540721 TABLET, FILM COATED in 1 BOTTLE (68788-8754-7) 2024-10-14NoNoHistorical
68788-8754-868788875408120 TABLET, FILM COATED in 1 BOTTLE (68788-8754-8) 2024-10-14NoNoHistorical
68788-8754-96878887540990 TABLET, FILM COATED in 1 BOTTLE (68788-8754-9) 2024-10-14NoNoHistorical