FDA.reportPublic FDA data

NDC 53489-580-01 - FOLIC ACID

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
53489-580
Requested NDC
53489-580-01
Package NDCs from labels
53489-580-07, 53489-580-06, 53489-580-01, 53489-580-03, 53489-580-05, 53489-580-10
Manufacturer
MUTUAL PHARMACEUTICAL COMPANY, INC.
Effective date
2006-09-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FOLIC ACID TABLETS USPMUTUAL PHARMACEUTICAL COMPANY, INC.2006-09-20HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53489-580-01FOLIC ACID100 in 1 BOTTLE, PLASTICTABLET1001
53489-580-03FOLIC ACID250 in 1 BOTTLE, PLASTICTABLET2501
53489-580-05FOLIC ACID500 in 1 BOTTLE, PLASTICTABLET5001
53489-580-06FOLIC ACID60 in 1 BOTTLE, PLASTICTABLET601
53489-580-07FOLIC ACID30 in 1 BOTTLE, PLASTICTABLET301
53489-580-10FOLIC ACID1000 in 1 BOTTLE, PLASTICTABLET10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-580FOLIC ACID (FOLIC ACID) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]16 package rows20070119_E2CAAB63-1E0D-44E8-B9A8-BDFB59CE1288.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
folic acidACTIVE INGREDIENT935E97BOY8FOLIC ACID (FOLIC ACID) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
folic acidACTIVE MOIETY935E97BOY8FOLIC ACID (FOLIC ACID) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
Corn starchINACTIVE INGREDIENTFOLIC ACID (FOLIC ACID) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
crospovidoneINACTIVE INGREDIENTFOLIC ACID (FOLIC ACID) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30FOLIC ACID (FOLIC ACID) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTFOLIC ACID (FOLIC ACID) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
povidoneINACTIVE INGREDIENTFOLIC ACID (FOLIC ACID) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4FOLIC ACID (FOLIC ACID) TABLET [MUTUAL PHARMACEUTICAL COMPANY, INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 3 of 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Folic AcidFOLIC ACIDProficient Rx LP32203472-8724-4ba7-b0be-d834c3d7f0742024-06-01Warnings, Adverse reactionsExact identifier
rxcui: 310410
FOLIC ACIDFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC141bb721-cd20-5bba-e063-6394a90ab8fa2024-03-20Warnings, Adverse reactionsExact identifier
rxcui: 310410
Folic AcidFOLIC ACIDModavar Pharmaceuticals LLC0eea15e4-7e5d-44e9-818b-a0bdf5271c782023-12-25Warnings, Adverse reactionsExact identifier
rxcui: 310410
Folic AcidFOLIC ACIDCadila Pharmaceuticals Limited103c2cdd-5822-48ba-b62a-e2b11aa444ef2023-12-23Warnings, Adverse reactionsExact identifier
rxcui: 310410
FOLIC ACIDFOLIC ACIDBryant Ranch Prepack0b263a1e-260b-4775-a76e-766add336f122023-12-04Warnings, Adverse reactionsExact identifier
rxcui: 310410
FOLIC ACIDFOLIC ACIDA-S Medication Solutions21f7ccf1-1de6-4a6e-b017-2b85c9d62d132023-10-19Warnings, Adverse reactionsExact identifier
rxcui: 310410
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLCf8ffce0d-2b94-4a14-a08e-97646436cf6d2023-06-15Warnings, Adverse reactionsExact identifier
rxcui: 310410
FOLIC ACIDFOLIC ACIDA-S Medication Solutionsa9583b76-822d-486a-947a-2be6356637d02023-05-09Warnings, Adverse reactionsExact identifier
rxcui: 310410
FOLIC ACIDFOLIC ACIDAphena Pharma Solutions - Tennessee, LLCdc4d097d-6e7e-4229-9853-04c31444d7032022-08-12Warnings, Adverse reactionsExact identifier
rxcui: 310410
FOLIC ACIDFOLIC ACIDProficient Rx LP607d23e8-21ef-4d73-88f1-990cf267d22e2022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 310410
Folic acidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLC454f9fdc-fd8c-4838-8e5b-10f4c74110dd2021-05-24Warnings, Adverse reactionsExact identifier
rxcui: 310410
FOLIC ACIDFOLIC ACIDLeading Pharma, LLC1ba8c407-9613-4319-ac40-0a429cb0f3f42019-02-19Warnings, Adverse reactionsExact identifier
rxcui: 310410
Folic AcidFOLIC ACIDAphena Pharma Solutions - Tennessee, LLCd6c7ac9b-f44a-4f10-9d1d-efbebd37c3132019-02-12Warnings, Adverse reactionsExact identifier
rxcui: 310410
E2CAAB63-1E0D-44E8-B9A8-BDFB59CE1288E2CAAB63-1E0D-44E8-B9A8-BDFB59CE12882006-09-20Warnings, Adverse reactionsExact identifier
spl id: E2CAAB63-1E0D-44E8-B9A8-BDFB59CE1288
spl set id: E2CAAB63-1E0D-44E8-B9A8-BDFB59CE1288

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.