Dicloxacillin Sodium

Product NDC
52959-049
11-digit product format
529590049
Labeler code
52959
Product ID
52959-049_8ff3da59-a3a2-4b6b-9445-3e578afe500e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dicloxacillin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA062286
Marketing category
ANDA
Marketing start
2011-01-20
Marketing end
0000-00-00
Substance
DICLOXACILLIN SODIUM
Active strength
500 mg/1
Pharmacologic classes
Penicillin-class Antibacterial [EPC],Penicillins [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-049-20Dicloxacillin Sodium20 in 1 BOTTLECAPSULE201
52959-049-21Dicloxacillin Sodium21 in 1 BOTTLECAPSULE211
52959-049-28Dicloxacillin Sodium28 in 1 BOTTLECAPSULE281
52959-049-30Dicloxacillin Sodium30 in 1 BOTTLECAPSULE301
52959-049-40Dicloxacillin Sodium40 in 1 BOTTLECAPSULE401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-049-20EA - Each52959-04940477a30-4511-42b1-8c69-fe8191868d5a12012-07-24
52959-049-21EA - Each52959-049c194b4f4-2174-4c3b-bb52-1e83d577047a12012-07-24
52959-049-28EA - Each52959-049165abc25-8ee2-49d1-99de-93f12c8d0a8c12012-07-24
52959-049-30EA - Each52959-04945a0a8a1-5f75-4556-b492-25123dd2e1e512012-07-24
52959-049-40EA - Each52959-04930ad5fdc-12fa-4aa7-892f-316ca8f5594f12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-049DICLOXACILLIN SODIUM CAPSULE [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 5 package rows20111208_3393668f-ea58-442e-b293-c7107b69d1af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197596dicloxacillin sodium 500 MG Oral CapsulePSN3393668f-ea58-442e-b293-c7107b69d1af1
197596dicloxacillin 500 MG Oral CapsuleSCD3393668f-ea58-442e-b293-c7107b69d1af1
197596dicloxacillin (as dicloxacillin sodium) 500 MG Oral CapsuleSY3393668f-ea58-442e-b293-c7107b69d1af1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-049-205295900492020 in 1 BOTTLEHistorical
52959-049-215295900492121 in 1 BOTTLEHistorical
52959-049-285295900492828 in 1 BOTTLEHistorical
52959-049-305295900493030 in 1 BOTTLEHistorical
52959-049-405295900494040 in 1 BOTTLEHistorical