FDA.reportPublic FDA data

Dicloxacillin Sodium

Product NDC
0440-7380
11-digit product format
004407380
Labeler code
0440
Product ID
0440-7380_1f007574-56f1-4695-be3a-aeb85c41d466
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicloxacillin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA062286
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
DICLOXACILLIN SODIUM
Active strength
250 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
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
ce7f6212-eff4-e8f0-b733-f4aa5877dfa0Product name220231211

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0440-7380-402020-01-31C16284748780-19d75b9d0-006d-f424-e053-dadaa90a57ceDICLOXACILLIN SODIUM CAPSULES USP 3123 3125 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-7380-40Dicloxacillin Sodium40 in 1 BOTTLE, PLASTICCAPSULE402

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOXACILLIN SODIUMACTIVE INGREDIENT4HZT2V9KX0DICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
DICLOXACILLINACTIVE MOIETYCOF19H7WBKDICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
SHELLACINACTIVE INGREDIENT46N107B71ODICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71JDICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-7380DICLOXACILLIN SODIUM CAPSULE [LIBERTY PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20130909_939f13c5-c394-49c1-ae57-edc44438a9de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197595dicloxacillin sodium 250 MG Oral CapsulePSN939f13c5-c394-49c1-ae57-edc44438a9de2
197595dicloxacillin 250 MG Oral CapsuleSCD939f13c5-c394-49c1-ae57-edc44438a9de2
197595dicloxacillin (as dicloxacillin sodium) 250 MG Oral CapsuleSY939f13c5-c394-49c1-ae57-edc44438a9de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0440-7380-400044073804040 in 1 BOTTLE, PLASTICHistorical