ibuprofen

Product NDC
73086-210
11-digit product format
730860210
Labeler code
73086
Product ID
73086-210_591f2c0c-8dd5-4f3b-9936-cd6485343639
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
SKYA HEALTH, LLC
Application
ANDA090796
Marketing category
ANDA
Marketing start
2024-03-20
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
73086-210-01ibuprofen100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73086-210-01EA - Each73086-21054cdde9e-f969-4242-bbb3-e777fef3752112024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73086-210IBUPROFEN TABLET [SKYA HEALTH, LLC]5Current NDC, 1 package rows20240704_1c28af16-7246-4e4c-a1be-939655c37242.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197805ibuprofen 400 MG Oral TabletPSN1c28af16-7246-4e4c-a1be-939655c372425
197806ibuprofen 600 MG Oral TabletPSN1c28af16-7246-4e4c-a1be-939655c372425
197807ibuprofen 800 MG Oral TabletPSN1c28af16-7246-4e4c-a1be-939655c372425
197805ibuprofen 400 MG Oral TabletSCD1c28af16-7246-4e4c-a1be-939655c372425
197806ibuprofen 600 MG Oral TabletSCD1c28af16-7246-4e4c-a1be-939655c372425
197807ibuprofen 800 MG Oral TabletSCD1c28af16-7246-4e4c-a1be-939655c372425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73086-210-0173086021001100 TABLET in 1 BOTTLE (73086-210-01) 100 tablet2024-03-20NoNoCurrent