FDA.reportPublic FDA data

Quality Choice Ibuprofen 200

Product NDC
63868-977
11-digit product format
638680977
Labeler code
63868
Product ID
63868-977_492aae4a-981f-4cd3-aac5-5ef838116e8c
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
ANDA079129
Marketing category
ANDA
Marketing start
2014-07-23
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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
63868-977-082020-01-31C16284748780-19d75b9d0-9f7f-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-977-08Quality Choice Ibuprofen 2008 in 1 BLISTER PACKTABLET82
63868-977-08Quality Choice Ibuprofen 2001 in 1 CARTONTABLET12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMQUALITY CHOICE IBUPROFEN 200 (IBUPROFEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2
IBUPROFENACTIVE MOIETYWK2XYI10QMQUALITY CHOICE IBUPROFEN 200 (IBUPROFEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UQUALITY CHOICE IBUPROFEN 200 (IBUPROFEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48QUALITY CHOICE IBUPROFEN 200 (IBUPROFEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTQUALITY CHOICE IBUPROFEN 200 (IBUPROFEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOQUALITY CHOICE IBUPROFEN 200 (IBUPROFEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4QUALITY CHOICE IBUPROFEN 200 (IBUPROFEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJQUALITY CHOICE IBUPROFEN 200 (IBUPROFEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APQUALITY CHOICE IBUPROFEN 200 (IBUPROFEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPQUALITY CHOICE IBUPROFEN 200 (IBUPROFEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-977QUALITY CHOICE IBUPROFEN 200 (IBUPROFEN) TABLET [CHAIN DRUG MARKETING ASSOCIATION]2Legacy NDC, 2 package rows20150612_13b43016-153f-468e-a4b8-858e0ffe5d99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN13b43016-153f-468e-a4b8-858e0ffe5d992
310965ibuprofen 200 MG Oral TabletSCD13b43016-153f-468e-a4b8-858e0ffe5d992
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY13b43016-153f-468e-a4b8-858e0ffe5d992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63868-977-08638680977088 in 1 BLISTER PACKHistorical