FDA.reportPublic FDA data

Folic Acid

Product NDC
65162-361
11-digit product format
651620361
Labeler code
65162
Product ID
65162-361_e5ed5369-340d-40ad-b863-c02fd63d5911
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Folic Acid
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA040625
Marketing category
ANDA
Marketing start
2009-12-02
Substance
FOLIC ACID
Active strength
1 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
65162-361-01Folic Acid10 in 1 BOTTLETABLET1017
65162-361-10Folic Acid100 in 1 BOTTLETABLET10017
65162-361-11Folic Acid1000 in 1 BOTTLETABLET100017
65162-361-50Folic Acid500 in 1 BOTTLETABLET50017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-361-10EA - Each65162-36173cf7ef2-4d46-44f6-bc81-6b85c1111a7b12012-07-24
65162-361-11EA - Each65162-361a3d3cadd-08f3-4a3d-bc9f-fb4dd27381cf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOLIC ACIDACTIVE INGREDIENT935E97BOY8FOLIC ACID TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
FOLIC ACIDACTIVE MOIETY935E97BOY8FOLIC ACID TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]9
FOLIC ACIDACTIVE INGREDIENT935E97BOY8FOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.]3
FOLIC ACIDACTIVE MOIETY935E97BOY8FOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.]3
FOLIC ACIDACTIVE INGREDIENT935E97BOY8FOLIC ACID TABLET [TYA PHARMACEUTICALS]2
FOLIC ACIDACTIVE INGREDIENT935E97BOY8FOLIC ACID TABLET [UNIT DOSE SERVICES]2
FOLIC ACIDACTIVE MOIETY935E97BOY8FOLIC ACID TABLET [TYA PHARMACEUTICALS]2
FOLIC ACIDACTIVE MOIETY935E97BOY8FOLIC ACID TABLET [UNIT DOSE SERVICES]2
FOLIC ACIDACTIVE INGREDIENT935E97BOY8FOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.]1
FOLIC ACIDACTIVE MOIETY935E97BOY8FOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XFOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2FOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-361FOLIC ACID TABLET [AMNEAL PHARMACEUTICALS LLC]17Current NDC, Legacy NDC, 4 package rows20241027_c8fe09f0-b32b-43e3-8de7-ed38593b33b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310410folic acid 1 MG Oral TabletPSNc8fe09f0-b32b-43e3-8de7-ed38593b33b417
310410folic acid 1 MG Oral TabletSCDc8fe09f0-b32b-43e3-8de7-ed38593b33b417
310410folate 1 MG Oral TabletSYc8fe09f0-b32b-43e3-8de7-ed38593b33b417
310410vitamin B9 1,000 MCG Oral TabletSYc8fe09f0-b32b-43e3-8de7-ed38593b33b417
310410folic acid 1 MG Oral TabletPSNed173b70-83cd-4541-b308-87ea32241e9c2
310410folic acid 1 MG Oral TabletPSN516d1136-4435-4a6f-88f8-0184b76a73cf2
310410folic acid 1 MG Oral TabletPSN8feec044-5896-4f54-8cb3-425f5c0d379f2
310410folic acid 1 MG Oral TabletSCDed173b70-83cd-4541-b308-87ea32241e9c2
310410folic acid 1 MG Oral TabletSCD516d1136-4435-4a6f-88f8-0184b76a73cf2
310410folic acid 1 MG Oral TabletSCD8feec044-5896-4f54-8cb3-425f5c0d379f2
310410folate 1 MG Oral TabletSYed173b70-83cd-4541-b308-87ea32241e9c2
310410folate 1 MG Oral TabletSY516d1136-4435-4a6f-88f8-0184b76a73cf2
310410folate 1 MG Oral TabletSY8feec044-5896-4f54-8cb3-425f5c0d379f2
310410vitamin B9 1,000 MCG Oral TabletSYed173b70-83cd-4541-b308-87ea32241e9c2
310410vitamin B9 1,000 MCG Oral TabletSY8feec044-5896-4f54-8cb3-425f5c0d379f2
310410vitamin B9 1,000 MCG Oral TabletSY516d1136-4435-4a6f-88f8-0184b76a73cf2
310410folic acid 1 MG Oral TabletPSNd6c7ac9b-f44a-4f10-9d1d-efbebd37c3131
310410folic acid 1 MG Oral TabletPSN2e2313cf-ee59-4b22-acb1-530c50c17ff21
310410folic acid 1 MG Oral TabletSCDd6c7ac9b-f44a-4f10-9d1d-efbebd37c3131
310410folic acid 1 MG Oral TabletSCD2e2313cf-ee59-4b22-acb1-530c50c17ff21
310410folate 1 MG Oral TabletSYd6c7ac9b-f44a-4f10-9d1d-efbebd37c3131
310410folate 1 MG Oral TabletSY2e2313cf-ee59-4b22-acb1-530c50c17ff21
310410vitamin B9 1,000 MCG Oral TabletSYd6c7ac9b-f44a-4f10-9d1d-efbebd37c3131
310410vitamin B9 1,000 MCG Oral TabletSY2e2313cf-ee59-4b22-acb1-530c50c17ff21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-361-016516203610110 TABLET in 1 BOTTLE (65162-361-01) 10 tablet2009-12-020000-00-00NoNoCurrent
65162-361-1065162036110100 TABLET in 1 BOTTLE (65162-361-10) 100 tablet2009-12-020000-00-00NoNoCurrent
65162-361-11651620361111000 TABLET in 1 BOTTLE (65162-361-11) 1000 tablet2009-12-020000-00-00NoNoCurrent
65162-361-5065162036150500 TABLET in 1 BOTTLE (65162-361-50) 500 tablet2009-12-020000-00-00NoNoCurrent