FDA.reportPublic FDA data

LEVOLEUCOVORIN

Product NDC
43598-773
11-digit product format
435980773
Labeler code
43598
Product ID
43598-773_2f5844a8-825f-6a4f-996e-17e21c369359
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LEVOLEUCOVORIN
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA210892
Marketing category
ANDA
Marketing start
2018-09-26
Substance
LEVOLEUCOVORIN CALCIUM
Active strength
250 mg/25mL
Pharmacologic classes
Folate Analog [EPC], Folic Acid [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
LEVOLEUCOVORIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOLEUCOVORIN CALCIUM250 mg/25mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii778XL6VBS8
Rxcui1720765, 1720773

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5f7850a-bc65-4866-8340-2b197ae4d8caProduct name920200206
2642c4da-5f9c-4531-8406-dc7d1c3a9032Product name120190201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-773-11LEVOLEUCOVORIN25 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION252
43598-773-11LEVOLEUCOVORIN1 in 1 CARTONINJECTION, SOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-773-11ML - Milliliter43598-77338cec18b-90d8-4904-a640-d2438eac055512018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-773LEVOLEUCOVORIN INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC]2Current NDC, Legacy NDC, 2 package rows20181206_c003aaed-89c3-d6a6-0d34-18851b7e1255.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1720765LEVOleucovorin 175 MG in 17.5 mL InjectionPSNc003aaed-89c3-d6a6-0d34-18851b7e12552
1720773LEVOleucovorin 250 MG in 25 ML InjectionPSNc003aaed-89c3-d6a6-0d34-18851b7e12552
172076517.5 ML levoleucovorin 10 MG/ML InjectionSCDc003aaed-89c3-d6a6-0d34-18851b7e12552
172077325 ML levoleucovorin 10 MG/ML InjectionSCDc003aaed-89c3-d6a6-0d34-18851b7e12552
1720765levoleucovorin (as levoleucovorin calcium) 175 MG per 17.5 mL InjectionSYc003aaed-89c3-d6a6-0d34-18851b7e12552
1720773levoleucovorin (as levoleucovorin calcium) 250 MG per 25 ML InjectionSYc003aaed-89c3-d6a6-0d34-18851b7e12552
1720765levoleucovorin 175 MG per 17.5 mL InjectionSYc003aaed-89c3-d6a6-0d34-18851b7e12552
1720773levoleucovorin 250 MG per 25 ML InjectionSYc003aaed-89c3-d6a6-0d34-18851b7e12552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43598-773-11435980773111 VIAL, SINGLE-DOSE in 1 CARTON (43598-773-11) / 25 mL in 1 VIAL, SINGLE-DOSE2018-09-260000-00-00NoNoCurrent