FDA.reportPublic FDA data

Ibuprofen

Product NDC
68788-4039
11-digit product format
687884039
Labeler code
68788
Product ID
68788-4039_a85080d7-50b4-461b-9d77-d6fbab971c03
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
2025-10-13
Substance
IBUPROFEN
Active strength
400 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
IBUPROFEN400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWK2XYI10QM
Rxcui197805

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
68788-4039-1Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1001
68788-4039-2Ibuprofen20 in 1 BOTTLETABLET, FILM COATED201
68788-4039-3Ibuprofen30 in 1 BOTTLETABLET, FILM COATED301
68788-4039-5Ibuprofen50 in 1 BOTTLETABLET, FILM COATED501
68788-4039-6Ibuprofen60 in 1 BOTTLETABLET, FILM COATED601
68788-4039-8Ibuprofen28 in 1 BOTTLETABLET, FILM COATED281
68788-4039-9Ibuprofen90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4039-1EA - Each68788-40390341c7fe-9b2f-4aa3-86a8-25d4542bc60312026-01-08
68788-4039-2EA - Each68788-40395c65a097-0380-464a-8219-f1dad2dbb7bf12026-01-08
68788-4039-3EA - Each68788-4039f25e90f1-6c65-4733-983a-a2b23af58e0912026-01-08
68788-4039-5EA - Each68788-40390d639c39-e0b6-45c5-9561-1d33a6696ce812026-01-08
68788-4039-6EA - Each68788-403953667275-2c8a-445e-bddd-6c308bdf00e512026-01-08
68788-4039-8EA - Each68788-40392d665892-ba22-4f33-b3b3-110ce73a7a4912026-01-08
68788-4039-9EA - Each68788-40399a5283af-4f8a-4587-885c-9631fc203db412026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSNa85080d7-50b4-461b-9d77-d6fbab971c031
197805ibuprofen 400 MG Oral TabletSCDa85080d7-50b4-461b-9d77-d6fbab971c031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4039-168788403901100 TABLET, FILM COATED in 1 BOTTLE (68788-4039-1) 2025-10-13NoNoCurrent
68788-4039-26878840390220 TABLET, FILM COATED in 1 BOTTLE (68788-4039-2) 2025-10-13NoNoCurrent
68788-4039-36878840390330 TABLET, FILM COATED in 1 BOTTLE (68788-4039-3) 2025-10-13NoNoCurrent
68788-4039-56878840390550 TABLET, FILM COATED in 1 BOTTLE (68788-4039-5) 2025-10-13NoNoCurrent
68788-4039-66878840390660 TABLET, FILM COATED in 1 BOTTLE (68788-4039-6) 2025-10-13NoNoCurrent
68788-4039-86878840390828 TABLET, FILM COATED in 1 BOTTLE (68788-4039-8) 2025-10-13NoNoCurrent
68788-4039-96878840390990 TABLET, FILM COATED in 1 BOTTLE (68788-4039-9) 2025-10-13NoNoCurrent