Dicloxacillin Sodium

Product NDC
43063-473
11-digit product format
430630473
Labeler code
43063
Product ID
43063-473_4138864e-9d78-23ff-e063-6294a90ac47c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicloxacillin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA062286
Marketing category
ANDA
Marketing start
1990-09-30
Substance
DICLOXACILLIN SODIUM
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicloxacillin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOXACILLIN SODIUM500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4HZT2V9KX0
Rxcui197596

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce7f6212-eff4-e8f0-b733-f4aa5877dfa0Product name220231211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43063-473-20Dicloxacillin Sodium20 in 1 BOTTLE, PLASTICCAPSULE2016
43063-473-30Dicloxacillin Sodium30 in 1 BOTTLE, PLASTICCAPSULE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-473-30EA - Each43063-473e5a0e04b-edf0-467f-860a-15ee8c9c9e1312018-04-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOXACILLIN SODIUMACTIVE INGREDIENT4HZT2V9KX0DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
DICLOXACILLINACTIVE MOIETYCOF19H7WBKDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71ODICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
SORBITAN MONOLAURATEINACTIVE INGREDIENT6W9PS8B71JDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-473DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 2 package rows20241013_24e821aa-85b8-4f5a-aa13-83ff132952ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197596dicloxacillin sodium 500 MG Oral CapsulePSN24e821aa-85b8-4f5a-aa13-83ff132952ca16
197596dicloxacillin 500 MG Oral CapsuleSCD24e821aa-85b8-4f5a-aa13-83ff132952ca16
197596dicloxacillin (as dicloxacillin sodium) 500 MG Oral CapsuleSY24e821aa-85b8-4f5a-aa13-83ff132952ca16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-473-204306304732020 CAPSULE in 1 BOTTLE, PLASTIC (43063-473-20) 20 capsule2012-12-060000-00-00NoNoCurrent
43063-473-304306304733030 CAPSULE in 1 BOTTLE, PLASTIC (43063-473-30) 30 capsule2012-12-060000-00-00NoNoCurrent