IBUPROFEN

Product NDC
53943-403
11-digit product format
539430403
Labeler code
53943
Product ID
53943-403_baf329a1-cef9-445e-8a16-26976e22f4cc
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Discount Drug Mart
Application
ANDA079129
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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53943-403-23IBUPROFENIMMEDIATE RELEASE50 in 1 BOTTLETABLET, COATED501
53943-403-23IBUPROFENIMMEDIATE RELEASE1 in 1 CARTONTABLET, COATED11
53943-403-24IBUPROFENIMMEDIATE RELEASE100 in 1 BOTTLETABLET, COATED1001
53943-403-24IBUPROFENIMMEDIATE RELEASE1 in 1 CARTONTABLET, COATED11
53943-403-29IBUPROFENIMMEDIATE RELEASE500 in 1 BOTTLETABLET, COATED5001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1
TRIACETININACTIVE INGREDIENTXHX3C3X673IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53943-403IBUPROFEN IMMEDIATE RELEASE (IBUPROFEN) TABLET, COATED [DISCOUNT DRUG MART]1Legacy NDC, 5 package rows20141222_baf329a1-cef9-445e-8a16-26976e22f4cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNbaf329a1-cef9-445e-8a16-26976e22f4cc1
310965ibuprofen 200 MG Oral TabletSCDbaf329a1-cef9-445e-8a16-26976e22f4cc1
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYbaf329a1-cef9-445e-8a16-26976e22f4cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53943-403-235394304032350 in 1 BOTTLEHistorical
53943-403-2453943040324100 in 1 BOTTLEHistorical
53943-403-2953943040329500 in 1 BOTTLEHistorical