FDA.reportPublic FDA data

Ibuprofen

Product NDC
68788-8319
11-digit product format
687888319
Labeler code
68788
Product ID
68788-8319_f854b253-22ef-4147-8608-d6c4f5446eb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA213794
Marketing category
ANDA
Marketing start
2022-12-23
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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8319-1Ibuprofen100 in 1 BOTTLETABLET1005
68788-8319-2Ibuprofen20 in 1 BOTTLETABLET205
68788-8319-3Ibuprofen30 in 1 BOTTLETABLET305
68788-8319-4Ibuprofen14 in 1 BOTTLETABLET145
68788-8319-5Ibuprofen50 in 1 BOTTLETABLET505
68788-8319-6Ibuprofen60 in 1 BOTTLETABLET605
68788-8319-7Ibuprofen21 in 1 BOTTLETABLET215
68788-8319-8Ibuprofen120 in 1 BOTTLETABLET1205
68788-8319-9Ibuprofen90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8319-1EA - Each68788-8319f3883028-6ac8-4772-9200-5e61f11717da12023-02-06
68788-8319-2EA - Each68788-8319e5d7777f-3de5-4376-ba5a-2eb6b670c8a712023-02-06
68788-8319-3EA - Each68788-8319af992a56-c786-470c-a2a9-6a1155b7e21312023-02-06
68788-8319-4EA - Each68788-831980f8f705-fe48-4ab6-b233-d825e2a2cb7912023-02-06
68788-8319-5EA - Each68788-8319a31ea324-5156-4e75-ab33-22ec75abdb4e12023-02-06
68788-8319-6EA - Each68788-8319086def3d-1181-4cd0-9308-4c2f36a628f012023-02-06
68788-8319-7EA - Each68788-8319734073ce-0e79-4af2-be7a-93f8ef2b3be312023-02-06
68788-8319-8EA - Each68788-83198369ddbc-618c-46ed-b50f-41a18199ed9612023-02-06
68788-8319-9EA - Each68788-83195bf583f9-d9d9-4f55-94fa-92db7c46ad6112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8319IBUPROFEN TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 9 package rows20240526_25d9f5fc-4d95-4018-add8-ba696b6079b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN25d9f5fc-4d95-4018-add8-ba696b6079b25
197807ibuprofen 800 MG Oral TabletSCD25d9f5fc-4d95-4018-add8-ba696b6079b25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8319-168788831901100 TABLET in 1 BOTTLE (68788-8319-1) 100 tablet2022-12-230000-00-00NoNoCurrent
68788-8319-26878883190220 TABLET in 1 BOTTLE (68788-8319-2) 20 tablet2022-12-230000-00-00NoNoCurrent
68788-8319-36878883190330 TABLET in 1 BOTTLE (68788-8319-3) 30 tablet2022-12-230000-00-00NoNoCurrent
68788-8319-46878883190414 TABLET in 1 BOTTLE (68788-8319-4) 14 tablet2022-12-230000-00-00NoNoCurrent
68788-8319-56878883190550 TABLET in 1 BOTTLE (68788-8319-5) 50 tablet2022-12-230000-00-00NoNoCurrent
68788-8319-66878883190660 TABLET in 1 BOTTLE (68788-8319-6) 60 tablet2022-12-230000-00-00NoNoCurrent
68788-8319-76878883190721 TABLET in 1 BOTTLE (68788-8319-7) 21 tablet2022-12-230000-00-00NoNoCurrent
68788-8319-868788831908120 TABLET in 1 BOTTLE (68788-8319-8) 120 tablet2022-12-230000-00-00NoNoCurrent
68788-8319-96878883190990 TABLET in 1 BOTTLE (68788-8319-9) 90 tablet2022-12-230000-00-00NoNoCurrent