FDA.reportPublic FDA data

Ibuprofen

Product NDC
76282-714
11-digit product format
762820714
Labeler code
76282
Product ID
76282-714_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
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
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
IBUPROFEN800 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
76282-714-10Ibuprofen100 in 1 BOTTLETABLET, FILM COATED1003
76282-714-30Ibuprofen30 in 1 BOTTLETABLET, FILM COATED303
76282-714-45Ibuprofen10 in 1 BLISTER PACKTABLET, FILM COATED103
76282-714-46Ibuprofen100 in 1 CARTONTABLET, FILM COATED1003
76282-714-50Ibuprofen500 in 1 BOTTLETABLET, FILM COATED5003
76282-714-55Ibuprofen1000 in 1 BOTTLETABLET, FILM COATED10003
76282-714-90Ibuprofen90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-714-10EA - Each76282-714b943827d-f4c8-4405-a6ed-5a1a6890c42d12022-07-06
76282-714-30EA - Each76282-7142bc2e8a3-1f05-4f9c-bcc8-215af260092612024-05-16
76282-714-46EA - Each76282-714fcbe06a5-4189-4b9c-9136-3d0a3a5212a012024-05-16
76282-714-50EA - Each76282-714d5fc7268-47aa-449c-9f41-235a3073576b12022-07-06
76282-714-90EA - Each76282-71480857d3e-1499-4191-8165-1da278583cee12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-714IBUPROFEN TABLET, FILM COATED [EXELAN PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 7 package rows20240427_362f934a-4382-43bc-bedd-65081286f1c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197807ibuprofen 800 MG Oral TabletPSN1e1b0266-011c-7cd1-e063-6394a90a5b344
197807ibuprofen 800 MG Oral TabletSCD1e1b0266-011c-7cd1-e063-6394a90a5b344
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
76282-714-1076282071410100 TABLET, FILM COATED in 1 BOTTLE (76282-714-10) 2022-03-100000-00-00NoNoCurrent
76282-714-307628207143030 TABLET, FILM COATED in 1 BOTTLE (76282-714-30) 2022-03-10NoNoHistorical
76282-714-457628207144510 in 1 BLISTER PACKHistorical
76282-714-4676282071446100 BLISTER PACK in 1 CARTON (76282-714-46) / 10 TABLET, FILM COATED in 1 BLISTER PACK (76282-714-45) 100 blister pack2022-03-10NoNoHistorical
76282-714-5076282071450500 TABLET, FILM COATED in 1 BOTTLE (76282-714-50) 2022-03-100000-00-00NoNoCurrent
76282-714-55762820714551000 TABLET, FILM COATED in 1 BOTTLE (76282-714-55) 2022-03-100000-00-00NoNoCurrent
76282-714-657628207146511400 TABLET, FILM COATED in 1 POUCH (76282-714-65) 2022-03-230000-00-00NoNoCurrent
76282-714-907628207149090 TABLET, FILM COATED in 1 BOTTLE (76282-714-90) 2022-03-10NoNoHistorical