FDA.reportPublic FDA data

Ibuprofen

Product NDC
53329-677
11-digit product format
533290677
Labeler code
53329
Product ID
53329-677_15821573-03c8-490f-9295-74430aa07dfe
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
TABLET
Route
ORAL
Labeler
Medline industries, Inc.
Application
ANDA076460
Marketing category
ANDA
Marketing start
2015-04-21
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
53329-677-302020-01-31C16284748780-19d75b9d0-70ea-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-677-30Ibuprofen1 in 1 CARTONTABLET11
53329-677-30Ibuprofen100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-677-30EA - Each53329-6772b33aac3-6d2a-4ba8-9290-812d7b1bdd5212018-05-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEIBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APIBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-677IBUPROFEN TABLET [MEDLINE INDUSTRIES, INC.]1Legacy NDC, 2 package rows20150502_15821573-03c8-490f-9295-74430aa07dfe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSN15821573-03c8-490f-9295-74430aa07dfe1
310965ibuprofen 200 MG Oral TabletSCD15821573-03c8-490f-9295-74430aa07dfe1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY15821573-03c8-490f-9295-74430aa07dfe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53329-677-30533290677301 in 1 CARTONHistorical