FDA.reportPublic FDA data

IBUPROFEN

Product NDC
12634-860
11-digit product format
126340860
Labeler code
12634
Product ID
12634-860_6e315790-ef94-4772-8e76-2565f8b097d4
Type
HUMAN OTC DRUG
Nonproprietary name
IBUPROFEN
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA071333
Marketing category
ANDA
Marketing start
2009-09-16
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
200 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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
12634-860-012020-01-31C16284748780-19d75b9cf-d96a-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (NSAID)Pain Reliever/ Fever Reducer DRUG FACTS
12634-860-102020-01-31C16284748780-19d75b9cf-d96a-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (NSAID)Pain Reliever/ Fever Reducer DRUG FACTS
12634-860-242020-01-31C16284748780-19d75b9cf-d96a-f424-e053-dadaa90a57ceIbuprofen Tablets, USP (NSAID)Pain Reliever/ Fever Reducer DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-860-01IBUPROFEN100 in 1 BOTTLE, PLASTICTABLET1003
12634-860-10IBUPROFEN1000 in 1 BOTTLE, PLASTICTABLET10003
12634-860-24IBUPROFEN24 in 1 BOTTLE, PLASTICTABLET243

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN TABLET [APOTHECA INC.]3
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN TABLET [APOTHECA INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKIBUPROFEN TABLET [APOTHECA INC.]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN TABLET [APOTHECA INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBUPROFEN TABLET [APOTHECA INC.]3
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN TABLET [APOTHECA INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBUPROFEN TABLET [APOTHECA INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EIBUPROFEN TABLET [APOTHECA INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN TABLET [APOTHECA INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JIBUPROFEN TABLET [APOTHECA INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN TABLET [APOTHECA INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN TABLET [APOTHECA INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-860IBUPROFEN TABLET [APOTHECA INC.]3Legacy NDC, 3 package rows20100224_a6e57acd-b02a-472e-9cc6-8d4aea246164.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310965ibuprofen 200 MG Oral TabletPSNa6e57acd-b02a-472e-9cc6-8d4aea2461643
310965ibuprofen 200 MG Oral TabletSCDa6e57acd-b02a-472e-9cc6-8d4aea2461643
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSYa6e57acd-b02a-472e-9cc6-8d4aea2461643

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-860-0112634086001100 in 1 BOTTLE, PLASTICHistorical
12634-860-10126340860101000 in 1 BOTTLE, PLASTICHistorical
12634-860-241263408602424 in 1 BOTTLE, PLASTICHistorical