FDA.reportPublic FDA data

KHAPZORY

Product NDC
72893-004
11-digit product format
728930004
Labeler code
72893
Product ID
72893-004_4b8997a9-ddf8-4618-966a-291d583f24f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levoleucovorin
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Acrotech Biopharma Inc
Application
NDA211226
Marketing category
NDA
Marketing start
2019-01-02
Substance
LEVOLEUCOVORIN DISODIUM
Active strength
175 mg/3.5mL
Pharmacologic classes
Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOLEUCOVORIN DISODIUM175 mg/3.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TXQ76K65T
Rxcui1858561, 2106373

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d5f7850a-bc65-4866-8340-2b197ae4d8caProduct name920200206
2642c4da-5f9c-4531-8406-dc7d1c3a9032Product name120190201
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72893-004-012023-05-10C16284748780-1f386c64a-2789-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use KHAPZORY® safely and effectively. See full prescribing information for KHAPZORY. KHAPZORY (levoleucovorin) for injection, for intravenous use Initial U.S. Approval: 1952 (d,l-leucovorin)
72893-004-012023-01-30C16284748780-1f386c64a-2789-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use KHAPZORY® safely and effectively. See full prescribing information for KHAPZORY. KHAPZORY (levoleucovorin) for injection, for intravenous use Initial U.S. Approval: 1952 (d,l-leucovorin)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72893-004-01KHAPZORY1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,112
72893-004-01KHAPZORY3.5 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,3.512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72893-004-01EA - Each72893-004bc5e194c-0fc6-482f-a6a0-edab2d720ea212021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72893-004KHAPZORY (LEVOLEUCOVORIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACROTECH BIOPHARMA INC]11Current NDC, Legacy NDC, 2 package rows20241213_344f65ac-9f04-49d7-b7c3-4ba19bd7b429.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2106373KHAPZORY 175 MG InjectionPSN344f65ac-9f04-49d7-b7c3-4ba19bd7b42912
1858561LEVOleucovorin 175 MG InjectionPSN344f65ac-9f04-49d7-b7c3-4ba19bd7b42912
2106373levoleucovorin 175 MG Injection [Khapzory]SBD344f65ac-9f04-49d7-b7c3-4ba19bd7b42912
1858561levoleucovorin 175 MG InjectionSCD344f65ac-9f04-49d7-b7c3-4ba19bd7b42912
2106373Khapzory 175 MG InjectionSY344f65ac-9f04-49d7-b7c3-4ba19bd7b42912
1858561levoleucovorin (as levoleucovorin calcium) 175 MG InjectionSY344f65ac-9f04-49d7-b7c3-4ba19bd7b42912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72893-004-01728930004011 VIAL in 1 CARTON (72893-004-01) / 3.5 mL in 1 VIAL1 vial2019-01-020000-00-00NoNoCurrent