Home NDC 65162-361 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 Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040625-001 FOLIC ACID FOLIC ACID 1MG TABLET / ORAL AA RS 2005-07-21
Therapeutic equivalence codes# Application-product, TE code table Application-product TE code A040625-001 AA
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Folic Acid FOLIC ACID Amneal Pharmaceuticals LLC c8fe09f0-b32b-43e3-8de7-ed38593b33b4 2024-10-25 Warnings, Adverse reactions Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings WARNING Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B 12 is deficient.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Folic acid is relatively nontoxic in man. Rare instances of allergic responses to folic acid preparations have been reported and have included erythema, skin rash, itching, general malaise, and respiratory difficulty due to bronchospasm. One patient experienced symptoms suggesting anaphylaxis following injection of the drug. Gastrointestinal side effects, including anorexia, nausea, abdominal distention, flatulence, and a bitter or bad taste, have been reported in patients receiving 15 mg folic acid daily for 1 month. Other side effects reported in patients receiving 15 mg daily include altered sleep patterns, difficulty in concentrating, irritability, overactivity, excitement, mental depression, confusion, and impaired judgment. Decreased vitamin B 12 serum levels may occur in patients receiving prolonged folic acid therapy. In an uncontrolled study, orally administered folic acid was reported to increase the incidence of seizures in some epileptic patients receiving phenobarbital, primidone, or diphenylhydantoin. Another investigator reported decreased diphenylhydantoin serum levels in folate-deficient patients receiving diphenylhydantoin who were treated with 5 mg or 15 mg of folic acid daily.
Additional Listing Data#
Finished product Yes
Brand name base Folic Acid
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOLIC ACID 1 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 935E97BOY8 Rxcui 310410
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65162-361-01 Folic Acid 10 in 1 BOTTLE TABLET 10 17 65162-361-10 Folic Acid 100 in 1 BOTTLE TABLET 100 17 65162-361-11 Folic Acid 1000 in 1 BOTTLE TABLET 1000 17 65162-361-50 Folic Acid 500 in 1 BOTTLE TABLET 500 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FOLIC ACID ACTIVE INGREDIENT 935E97BOY8 FOLIC ACID TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 9 FOLIC ACID ACTIVE MOIETY 935E97BOY8 FOLIC ACID TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 9 FOLIC ACID ACTIVE INGREDIENT 935E97BOY8 FOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.] 3 FOLIC ACID ACTIVE MOIETY 935E97BOY8 FOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FOLIC ACID TABLET [PD-RX PHARMACEUTICALS, INC.] 3 FOLIC ACID ACTIVE INGREDIENT 935E97BOY8 FOLIC ACID TABLET [TYA PHARMACEUTICALS] 2 FOLIC ACID ACTIVE INGREDIENT 935E97BOY8 FOLIC ACID TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 FOLIC ACID ACTIVE INGREDIENT 935E97BOY8 FOLIC ACID TABLET [AMERICAN HEALTH PACKAGING] 2 FOLIC ACID ACTIVE INGREDIENT 935E97BOY8 FOLIC ACID TABLET [UNIT DOSE SERVICES] 2 FOLIC ACID ACTIVE MOIETY 935E97BOY8 FOLIC ACID TABLET [TYA PHARMACEUTICALS] 2 FOLIC ACID ACTIVE MOIETY 935E97BOY8 FOLIC ACID TABLET [UNIT DOSE SERVICES] 2 FOLIC ACID ACTIVE MOIETY 935E97BOY8 FOLIC ACID TABLET [AMERICAN HEALTH PACKAGING] 2 FOLIC ACID ACTIVE MOIETY 935E97BOY8 FOLIC ACID TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FOLIC ACID TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FOLIC ACID TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FOLIC ACID TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FOLIC ACID TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS] 2 FOLIC ACID ACTIVE INGREDIENT 935E97BOY8 FOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.] 1 FOLIC ACID ACTIVE MOIETY 935E97BOY8 FOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X FOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP FOLIC ACID TABLET [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-361 FOLIC ACID TABLET [AMNEAL PHARMACEUTICALS LLC] 17 Current NDC, Legacy NDC, 4 package rows 20241027_c8fe09f0-b32b-43e3-8de7-ed38593b33b4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65162-361-01 65162036101 10 TABLET in 1 BOTTLE (65162-361-01) 10 tablet 2009-12-02 0000-00-00 No No Current 65162-361-10 65162036110 100 TABLET in 1 BOTTLE (65162-361-10) 100 tablet 2009-12-02 0000-00-00 No No Current 65162-361-11 65162036111 1000 TABLET in 1 BOTTLE (65162-361-11) 1000 tablet 2009-12-02 0000-00-00 No No Current 65162-361-50 65162036150 500 TABLET in 1 BOTTLE (65162-361-50) 500 tablet 2009-12-02 0000-00-00 No No Current