FDA.reportPublic FDA data

Ibuprofen

Product NDC
76282-712
11-digit product format
762820712
Labeler code
76282
Product ID
76282-712_bc309c22-f359-42b1-86db-3970a5d53bc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
EXELAN PHARMACEUTICALS, INC.
Application
ANDA091625
Marketing category
ANDA
Marketing start
2022-03-10
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, 197806, 197807

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
76282-712-10Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1003
76282-712-45Ibuprofen10 in 1 BLISTER PACKTABLET, FILM COATED103
76282-712-46Ibuprofen100 in 1 CARTONTABLET, FILM COATED1003
76282-712-50Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5003
76282-712-55Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-712-10EA - Each76282-7122343b0c2-6b26-452a-bf3e-7ccf5a16440912022-07-06
76282-712-46EA - Each76282-7127654eb5d-d2b5-4187-b98e-26e2c1806bce12024-05-16
76282-712-50EA - Each76282-71245620b2e-ab4a-4a2a-aafd-1ce915be21d712022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-712IBUPROFEN TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 5 package rows20240427_362f934a-4382-43bc-bedd-65081286f1c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN362f934a-4382-43bc-bedd-65081286f1c93
197806ibuprofen 600 MG Oral TabletPSN362f934a-4382-43bc-bedd-65081286f1c93
197807ibuprofen 800 MG Oral TabletPSN362f934a-4382-43bc-bedd-65081286f1c93
197805ibuprofen 400 MG Oral TabletSCD362f934a-4382-43bc-bedd-65081286f1c93
197806ibuprofen 600 MG Oral TabletSCD362f934a-4382-43bc-bedd-65081286f1c93
197807ibuprofen 800 MG Oral TabletSCD362f934a-4382-43bc-bedd-65081286f1c93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-712-1076282071210100 TABLET, FILM COATED in 1 BOTTLE (76282-712-10) 2022-03-100000-00-00NoNoCurrent
76282-712-457628207124510 in 1 BLISTER PACKHistorical
76282-712-4676282071246100 BLISTER PACK in 1 CARTON (76282-712-46) / 10 TABLET, FILM COATED in 1 BLISTER PACK (76282-712-45) 100 blister pack2022-03-10NoNoCurrent
76282-712-5076282071250500 TABLET, FILM COATED in 1 BOTTLE (76282-712-50) 2022-03-100000-00-00NoNoCurrent
76282-712-55762820712551000 TABLET, FILM COATED in 1 BOTTLE (76282-712-55) 2022-03-100000-00-00NoNoCurrent
76282-712-647628207126410000 TABLET, FILM COATED in 1 POUCH (76282-712-64) 2022-03-230000-00-00NoNoCurrent