DICLOXACILLIN SODIUM

Product NDC
59651-565
11-digit product format
596510565
Labeler code
59651
Product ID
59651-565_faee6e2d-1b9c-4121-bc22-41313539b366
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DICLOXACILLIN SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216845
Marketing category
ANDA
Marketing start
2022-09-23
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, 197596

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
59651-565-01DICLOXACILLIN SODIUM100 in 1 BOTTLECAPSULE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-565-01EA - Each59651-5654e8485fc-f170-406e-be84-e47be95815e212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-565DICLOXACILLIN SODIUM CAPSULE [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 1 package rows20231229_9074b5a6-850c-4144-9097-bb21073ee54d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197595dicloxacillin sodium 250 MG Oral CapsulePSN9074b5a6-850c-4144-9097-bb21073ee54d2
197596dicloxacillin sodium 500 MG Oral CapsulePSN9074b5a6-850c-4144-9097-bb21073ee54d2
197595dicloxacillin 250 MG Oral CapsuleSCD9074b5a6-850c-4144-9097-bb21073ee54d2
197596dicloxacillin 500 MG Oral CapsuleSCD9074b5a6-850c-4144-9097-bb21073ee54d2
197595dicloxacillin (as dicloxacillin sodium) 250 MG Oral CapsuleSY9074b5a6-850c-4144-9097-bb21073ee54d2
197596dicloxacillin (as dicloxacillin sodium) 500 MG Oral CapsuleSY9074b5a6-850c-4144-9097-bb21073ee54d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-565-0159651056501100 CAPSULE in 1 BOTTLE (59651-565-01) 100 capsule2022-09-230000-00-00NoNoCurrent