FDA.reportPublic FDA data

Dicloxacillin Sodium

Product NDC
55289-592
11-digit product format
552890592
Labeler code
55289
Product ID
55289-592_419b12d0-b5a9-5656-e063-6394a90a2d15
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
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 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
55289-592-10Dicloxacillin Sodium10 in 1 BOTTLE, PLASTICCAPSULE1016
55289-592-20Dicloxacillin Sodium20 in 1 BOTTLE, PLASTICCAPSULE2016
55289-592-28Dicloxacillin Sodium28 in 1 BOTTLE, PLASTICCAPSULE2816
55289-592-40Dicloxacillin Sodium40 in 1 BOTTLE, PLASTICCAPSULE4016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-592-10EA - Each55289-59218d9dc9a-8e5e-48e3-8c75-95604d451afe12012-07-24
55289-592-20EA - Each55289-5924a26060e-6390-406f-839b-7ae7e8d1c75812012-07-24
55289-592-28EA - Each55289-592fad28969-e8c3-412c-a4c0-e2217e467af612012-07-24
55289-592-40EA - Each55289-592a31dffd7-9dbf-4494-b485-ed40b11a49a112012-07-24

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
55289-592DICLOXACILLIN SODIUM CAPSULE [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 4 package rows20241012_9e2bbe03-44cb-45d1-acdb-b61d9016055e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197595dicloxacillin sodium 250 MG Oral CapsulePSN9e2bbe03-44cb-45d1-acdb-b61d9016055e16
197595dicloxacillin 250 MG Oral CapsuleSCD9e2bbe03-44cb-45d1-acdb-b61d9016055e16
197595dicloxacillin (as dicloxacillin sodium) 250 MG Oral CapsuleSY9e2bbe03-44cb-45d1-acdb-b61d9016055e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-592-105528905921010 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-10) 10 capsule2011-01-200000-00-00NoNoCurrent
55289-592-205528905922020 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-20) 20 capsule2011-01-200000-00-00NoNoCurrent
55289-592-285528905922828 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-28) 28 capsule2011-01-200000-00-00NoNoCurrent
55289-592-405528905924040 CAPSULE in 1 BOTTLE, PLASTIC (55289-592-40) 40 capsule2011-01-200000-00-00NoNoCurrent