FDA.reportPublic FDA data

Folic Acid

Product NDC
68788-8557
11-digit product format
687888557
Labeler code
68788
Product ID
68788-8557_a45f83d1-e6fa-4301-8868-e858d177f882
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Folic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211064
Marketing category
ANDA
Marketing start
2023-12-12
Substance
FOLIC ACID
Active strength
1 mg/1
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 ACID1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii935E97BOY8
Rxcui310410

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
68788-8557-1Folic Acid100 in 1 BOTTLETABLET1004
68788-8557-3Folic Acid30 in 1 BOTTLETABLET304
68788-8557-6Folic Acid60 in 1 BOTTLETABLET604
68788-8557-9Folic Acid90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8557-1EA - Each68788-8557900c8174-c358-4adf-93b0-72428e11e31812024-04-05
68788-8557-3EA - Each68788-8557adc72f62-06fc-4e7f-9a03-e3bb8e1ec03112024-04-05
68788-8557-6EA - Each68788-8557467af177-d5c8-4cda-9881-0733a3f3645d12024-04-05
68788-8557-9EA - Each68788-85579ca30736-135b-4150-91ea-2b4ef885efcf12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8557FOLIC ACID TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20240504_b4c3a754-64cd-499a-a32f-a6e935c41355.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310410folic acid 1 MG Oral TabletPSNb4c3a754-64cd-499a-a32f-a6e935c413554
310410folic acid 1 MG Oral TabletSCDb4c3a754-64cd-499a-a32f-a6e935c413554
310410folate 1 MG Oral TabletSYb4c3a754-64cd-499a-a32f-a6e935c413554
310410vitamin B9 1,000 MCG Oral TabletSYb4c3a754-64cd-499a-a32f-a6e935c413554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8557-168788855701100 TABLET in 1 BOTTLE (68788-8557-1) 100 tablet2023-12-12NoNoHistorical
68788-8557-36878885570330 TABLET in 1 BOTTLE (68788-8557-3) 30 tablet2023-12-12NoNoHistorical
68788-8557-66878885570660 TABLET in 1 BOTTLE (68788-8557-6) 60 tablet2023-12-12NoNoHistorical
68788-8557-96878885570990 TABLET in 1 BOTTLE (68788-8557-9) 90 tablet2023-12-12NoNoHistorical