Folic Acid
NDC 10135-182
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
Folic Acid is a ANDA-approved product labeled by Marlex Pharmaceuticals Inc. Folic acid is the man-made form of folate. It is supplied as a yellow product. This product entry covers the primary NDC 10135-182 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
10135-182
Proprietary Name:
Folic Acid
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
10135
Product Label ID:
FDA Application Number: [6]
ANDA204418
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
02-01-2016
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Product Characteristics
Color(s):
YELLOW (C48330)
Shape:
ROUND (C48348)
Size(s):
8 MM
Imprint(s):
N;8
Score:
2
Code Structure Chart
Product Details
What is NDC 10135-182?
The NDC code 10135-182 is assigned by the FDA to the product Folic Acid. This pharmaceutical product is labeled by Marlex Pharmaceuticals Inc and is currently categorized as listed product. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 10135-182-01, 10135-182-10. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
Folic acid is the man-made form of folate. Folate is a B-vitamin naturally found in some foods. It is needed to form healthy cells, especially red blood cells. Folic acid supplements may come in different forms (such as L-methylfolate, levomefolate, methyltetrahydrofolate). They are used to treat or prevent low folate levels. Low folate levels can lead to certain types of anemia. Conditions that can cause low folate levels include poor diet, pregnancy, alcoholism, liver disease, certain stomach/intestinal problems, kidney dialysis, among others. Women of childbearing age should receive adequate amounts of folic acid either through their diet or supplements to prevent infant spinal cord birth defects.
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- FOLIC ACID (UNII: 935E97BOY8)
- FOLIC ACID (UNII: 935E97BOY8) (Active Moiety)
Which are the Inactive Ingredients associated UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
- SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
- STEARIC ACID (UNII: 4ELV7Z65AP)
What is the NDC to RxNorm Crosswalk for this product?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
- RxCUI: 310410 - folic acid 1 MG Oral Tablet
- RxCUI: 310410 - folate 1 MG Oral Tablet
- RxCUI: 310410 - vitamin B9 1,000 MCG Oral Tablet
* Please review the full disclaimer at the bottom of this page.
Patient Education
Folic Acid
Folic acid is used to treat or prevent folic acid deficiency. It is a B-complex vitamin needed by the body to manufacture red blood cells. A deficiency of this vitamin causes certain types of anemia (low red blood cell count).
[Learn More]
Folic Acid
What is it? Folate and folic acid are forms of vitamin B9 used for deficiency and to prevent pregnancy complications. Many foods contain folate or have folic acid added.
Since 1998, folic acid has been added to cold cereals, flour, breads, pasta, bakery items, cookies, and crackers, as required by federal law. Foods that are naturally high in folate include leafy vegetables, okra, asparagus, certain fruits, beans, yeast, mushrooms, animal liver and kidney, orange juice, and tomato juice. Folic acid is also available as a supplement, and is often used in combination with other B vitamins.
Folic acid is used for preventing and treating low blood levels of folate (folate deficiency) and high blood levels of homocysteine (hyperhomocysteinemia). People who are pregnant or might become pregnant take folic acid to prevent serious birth defects such as spina bifida. Folic acid is also used for many other conditions including depression, stroke, decline in memory and thinking skills, and many others.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".
