NDC 72380-916 Folinex

Vitamin C, Vitamin B12, Vitamin K Mk7, Folate

NDC Product Code 72380-916

NDC CODE: 72380-916

Proprietary Name: Folinex What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Vitamin C, Vitamin B12, Vitamin K Mk7, Folate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Drug uses not available
  • 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.

NDC Code Structure

  • 72380 - Vivera Pharmaceuticals, Inc.

NDC 72380-916-30

Package Description: 30 CAPSULE in 1 BOTTLE

NDC Product Information

Folinex with NDC 72380-916 is a a human prescription drug product labeled by Vivera Pharmaceuticals, Inc.. The generic name of Folinex is vitamin c, vitamin b12, vitamin k mk7, folate. The product's dosage form is capsule and is administered via oral form.

Labeler Name: Vivera Pharmaceuticals, Inc.

Dosage Form: Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Folinex Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ASCORBIC ACID 355 mg/1
  • METHYLCOBALAMIN 1 mg/1
  • VITAMIN K7 100 ug/1
  • FOLIC ACID 1 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • GELATIN (UNII: 2G86QN327L)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Vivera Pharmaceuticals, Inc.
Labeler Code: 72380
Marketing Category: UNAPPROVED DRUG OTHER - 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.

Start Marketing Date: 02-07-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Folinex Product Label Images

Folinex Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

FACTSFolinex™ is an orally administered prescription folateproduct for the dietary management of patients withunique nutritional needs requiring increased folatelevels and other nutritional supplementation.Folinex™ should be administered under the supervisionof a licensed medical practitioner.Folinex™ is used for dietary management of patientswith unique nutritional needs requiring increasedfolate levels, or are in need of other nutritionalsupplementation. Folinex™ can be taken by womenof childbearing age, pregnant women, and lactatingand nonlactating mothers under the supervision of alicensed medical practitioner.

Precautions

PRECAUTIONSTell your doctor if you have: kidney problems or thyroiddisease. This medication should be used as directedduring pregnancy or while breast-feeding. Consultyour doctor about the risks and benefits. Folic acid alone isimproper therapy in the treatment of pernicious anemiaand other megaloblastic anemias where vitamin B12 isdeficient. Folic acid in doses above 0.1 mg daily mayobscure pernicious anemia in that hematologic remissioncan occur while neurological manifestations progress.

Warnings

WARNINGSAllergic sensitization has been reported following bothoral and parenteral administration of folic acid. Youshould call your doctor for medical advice about seriousadverse events.

Dosage & Administration

DOSAGE AND ADMINISTRATIONUsual adult dose is one (1) tablet once or twice daily or asprescribed by a licensed medical practitioner.*

Pregnancy

If you are pregnant or nursing, ask ahealthcare professional.

Other Safety Information

KEEP OUT OF THE REACH OF CHILDREN.Store at 20°-25°C (68°-77°F); excursions permittedto 15°-30°C (59°-86°F) [See USP Controlled RoomTemperature.] Protect from heat, light and moisture.Do not use if seal is broken or missing.

* This product is a prescription-folate with or without other dietaryingredients that – due to increased folate levels (AUG 2 1973 FR20750), requires an Rx on the label because of increased riskassociated with masking of B12 deficiency (pernicious anemia). Basedon our assessment of the risk of obscuring pernicious anemia, thisproduct requires licensed medical supervision, an Rx status, and aNational Drug Code (NDC) – or similarly-formatted product code, asrequired by pedigree reporting requirements and supply-chain controlas well as – in some cases, for insurance-reimbursement applications.

How Supplied

Folinex™ capsules are supplied as a solid, opaque,white, oblong capsule with “916” printed on oneside, dispensed in child-resistant bottles of 30ct(72380-916-30*).

Package Label

NDC# 72380-916-30VIVERA™PHARMACEUTICALSFolinex™30 CapsulesDispensed by Prescription OnlySupplement FactsServing Size: 1 Capsule       Servings per container: 30                          Amount Per Serving    %Daily ValueVitamin C                   500 mg                         555%(Ascorbic Acid)Vitamin B12                1 mg                        41,666%(as Methylcobalamin)Vitamin K MK7             100 mcg                         83%Folate                         1700 mcg DFE               425%                              (1 mg Folic Acid)Other ingredients: Gelatin, MagnesiumStearate, Microcrystalline Cellulose, DicalciumPhosphate, Silicon Dioxide, Titanium DioxideDosage: Adult dose is one (1) capsuleonce or twice daily or as prescribed by alicensed medical practitioner.If you are pregnant or nursing, ask ahealthcare professional.KEEP OUT OF REACH OF CHILDRENSTORAGE: Store at 20°-25°C (68°-77°F);excusions permitted to 15°-30°C (59°-86°F)[See USP Controlled Room Temperature.]Protect from heat, light , and moistureManufactured for:Vivera Pharmaceuticals, Inc.11100 Greenstone Ave.Santa Fe Springs, CA 90670MADE IN THE U.S.A.         REV120519LOT NO:EXP. DATE:MFG. DATE:3  72389  00004  9RES

* Please review the disclaimer below.