Dicloxacillin Sodium

Product NDC
43063-180
11-digit product format
430630180
Labeler code
43063
Product ID
43063-180_525a6123-2f84-bb54-e063-6294a90a7406
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
250 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dicloxacillin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOXACILLIN SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4HZT2V9KX0
Rxcui197595

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
43063-180-06Dicloxacillin Sodium6 in 1 BOTTLECAPSULE622

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-180-06EA - Each43063-18014834415-6d4b-444a-b2b1-424fe4a7573d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DICLOXACILLIN SODIUMACTIVE INGREDIENT4HZT2V9KX0DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
DICLOXACILLINACTIVE MOIETYCOF19H7WBKDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-180DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 1 package rows20241012_c17cd62d-ff5d-47ba-8673-3346c7f2365f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197595dicloxacillin sodium 250 MG Oral CapsulePSNc17cd62d-ff5d-47ba-8673-3346c7f2365f22
197595dicloxacillin 250 MG Oral CapsuleSCDc17cd62d-ff5d-47ba-8673-3346c7f2365f22
197595dicloxacillin (as dicloxacillin sodium) 250 MG Oral CapsuleSYc17cd62d-ff5d-47ba-8673-3346c7f2365f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-180-06430630180066 CAPSULE in 1 BOTTLE (43063-180-06) 6 capsule2009-08-110000-00-00NoNoCurrent