Folic Acid

Product NDC
39822-1100
11-digit product format
398221100
Labeler code
39822
Product ID
39822-1100_48eb23cf-7425-a5cc-e063-6294a90a5021
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Folic Acid
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
XGen Pharmaceuticals DJB, Inc.
Application
ANDA202522
Marketing category
ANDA
Marketing start
2019-11-17
Substance
FOLIC ACID
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOLIC ACID5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii935E97BOY8
Rxcui237786

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39822-1100-1Folic Acid1 in 1 CARTONINJECTION, SOLUTION15
39822-1100-1Folic Acid10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39822-1100-1ML - Milliliter39822-1100d53e7829-a80c-4eb3-9cd0-205cc4a6955412020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39822-1100FOLIC ACID INJECTION, SOLUTION [XGEN PHARMACEUTICALS DJB, INC.]4Current NDC, Legacy NDC, 2 package rows20220223_c5b2b84d-9f5e-4b81-ba10-9f2854e5dce9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237786folic acid 5 MG/ML injectable SolutionPSNc5b2b84d-9f5e-4b81-ba10-9f2854e5dce95
237786folic acid 5 MG/ML Injectable SolutionSCDc5b2b84d-9f5e-4b81-ba10-9f2854e5dce95
237786folate 5 MG/ML Injectable SolutionSYc5b2b84d-9f5e-4b81-ba10-9f2854e5dce95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
39822-1100-1398221100011 VIAL, MULTI-DOSE in 1 CARTON (39822-1100-1) / 10 mL in 1 VIAL, MULTI-DOSE2019-11-170000-00-00NoNoCurrent