FDA.reportPublic FDA data

LEVOLEUCOVORIN CALCIUM

Product NDC
70436-209
11-digit product format
704360209
Labeler code
70436
Product ID
70436-209_041b2b7e-33b8-a347-e063-6394a90acbc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
levoleucovorin injection
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Slate Run Pharmaceuticals
Application
ANDA217314
Marketing category
ANDA
Marketing start
2023-08-01
Substance
LEVOLEUCOVORIN CALCIUM
Active strength
10 mg/mL
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 CALCIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOLEUCOVORIN CALCIUM10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii778XL6VBS8
Rxcui1720765, 1720773

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
d5f7850a-bc65-4866-8340-2b197ae4d8caProduct name920200206
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2642c4da-5f9c-4531-8406-dc7d1c3a9032Product name120190201
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70436-209-80LEVOLEUCOVORIN CALCIUM17.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION17.51
70436-209-80LEVOLEUCOVORIN CALCIUM1 in 1 CARTONINJECTION, SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-209-80ML - Milliliter70436-209360c0071-ac9b-4a5b-8e39-8524da0bfc4512024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-209LEVOLEUCOVORIN CALCIUM (LEVOLEUCOVORIN INJECTION) INJECTION, SOLUTION [SLATE RUN PHARMACEUTICALS]1Current NDC, 2 package rows20230830_124bc214-62f8-40f9-a227-a35e2d1ff2a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1720765LEVOleucovorin 175 MG in 17.5 mL InjectionPSN124bc214-62f8-40f9-a227-a35e2d1ff2a01
1720773LEVOleucovorin 250 MG in 25 ML InjectionPSN124bc214-62f8-40f9-a227-a35e2d1ff2a01
172076517.5 ML levoleucovorin 10 MG/ML InjectionSCD124bc214-62f8-40f9-a227-a35e2d1ff2a01
172077325 ML levoleucovorin 10 MG/ML InjectionSCD124bc214-62f8-40f9-a227-a35e2d1ff2a01
1720765levoleucovorin (as levoleucovorin calcium) 175 MG per 17.5 mL InjectionSY124bc214-62f8-40f9-a227-a35e2d1ff2a01
1720773levoleucovorin (as levoleucovorin calcium) 250 MG per 25 ML InjectionSY124bc214-62f8-40f9-a227-a35e2d1ff2a01
1720765levoleucovorin 175 MG per 17.5 mL InjectionSY124bc214-62f8-40f9-a227-a35e2d1ff2a01
1720773levoleucovorin 250 MG per 25 ML InjectionSY124bc214-62f8-40f9-a227-a35e2d1ff2a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70436-209-80704360209801 VIAL, SINGLE-DOSE in 1 CARTON (70436-209-80) / 17.5 mL in 1 VIAL, SINGLE-DOSE2023-08-01NoNoCurrent