Ibuprofen

Product NDC
63654-363
11-digit product format
636540363
Labeler code
63654
Product ID
63654-363_82a1d588-5ad1-4ab9-8bdb-bfa044823dee
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen 200 mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Selder, S.A. de C.V.
Application
ANDA079205
Marketing category
ANDA
Marketing start
2014-12-22
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63654-363-402025-01-30C16284748780-12cef2736-76f8-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63654-363-40IbuprofenSoftgels40 in 1 BOTTLECAPSULE, LIQUID FILLED401
63654-363-40IbuprofenSoftgels1 in 1 CARTONCAPSULE, LIQUID FILLED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63654-363IBUPROFEN SOFTGELS (IBUPROFEN 200 MG) CAPSULE, LIQUID FILLED [SELDER, S.A. DE C.V.]1Legacy NDC, 2 package rows20181212_6f1b4964-4eb8-459c-9cb8-92ea93103f5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310964ibuprofen 200 MG Oral CapsulePSN6f1b4964-4eb8-459c-9cb8-92ea93103f5b1
310964ibuprofen 200 MG Oral CapsuleSCD6f1b4964-4eb8-459c-9cb8-92ea93103f5b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63654-363-40636540363401 BOTTLE in 1 CARTON (63654-363-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2014-12-220000-00-00NoNoCurrent