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  4. NDC Product Code: 85477-322 Embriva

NDC 85477-322 Embriva

Ascorbic Acid,Cholecalciferol,Thiamine,Pyridoxal Phosphate,Folic - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 85477-322?
  5. Embriva Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. Pharmacologic Classes

Product Information

Get all the details for National Drug Code (NDC) 85477-322 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
85477-322
Proprietary Name:
Embriva
Non-Proprietary Name: [1]
Ascorbic Acid, Cholecalciferol, Thiamine, Pyridoxal Phosphate, Folic Acid, Methylcobalamin, Calcium Carbonate, Ferrous Gluconate, Potassium Iodide
Substance Name: [2]
Ascorbic Acid; Calcium Carbonate; Cholecalciferol; Ferrous Gluconate; Folic Acid; Methylcobalamin; Potassium Iodide; Pyridoxal Phosphate Anhydrous; Thiamine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Oncora Pharma, Llc
Labeler Code:
85477
Product Label ID:
3c362de4-1ed9-83be-e063-6394a90a10fc
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date: [9]
08-08-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
OVAL (C48345)
Size(s):
19 MM
Score:
1

Code Structure Chart

Product Details

What is NDC 85477-322?

The NDC code 85477-322 is assigned by the FDA to the product Embriva which is a human prescription drug product labeled by Oncora Pharma, Llc. The generic name of Embriva is ascorbic acid, cholecalciferol, thiamine, pyridoxal phosphate, folic acid, methylcobalamin, calcium carbonate, ferrous gluconate, potassium iodide. The product's dosage form is tablet and is administered via oral form. The product is distributed in a single package with assigned NDC code 85477-322-30 30 tablet in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Embriva?

Prenatal and Postnatal prescriptive Folic Acid

What are Embriva Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ASCORBIC ACID 125 mg/1 - A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.
  • CALCIUM CARBONATE 200 mg/1 - Carbonic acid calcium salt (CaCO3). An odorless, tasteless powder or crystal that occurs in nature. It is used therapeutically as a phosphate buffer in hemodialysis patients and as a calcium supplement.
  • CHOLECALCIFEROL .0125 mg/1 - Derivative of 7-dehydroxycholesterol formed by ULTRAVIOLET RAYS breaking of the C9-C10 bond. It differs from ERGOCALCIFEROL in having a single bond between C22 and C23 and lacking a methyl group at C24.
  • FERROUS GLUCONATE 13 mg/1
  • FOLIC ACID 1 mg/1 - A member of the vitamin B family that stimulates the hematopoietic system. It is present in the liver and kidney and is found in mushrooms, spinach, yeast, green leaves, and grasses (POACEAE). Folic acid is used in the treatment and prevention of folate deficiencies and megaloblastic anemia.
  • METHYLCOBALAMIN 1 mg/1
  • POTASSIUM IODIDE .15 mg/1 - An inorganic compound that is used as a source of iodine in thyrotoxic crisis and in the preparation of thyrotoxic patients for thyroidectomy. (From Dorland, 27th ed)
  • PYRIDOXAL PHOSPHATE ANHYDROUS 2.5 mg/1
  • THIAMINE 1.4 mg/1 - 3-((4-Amino-2-methyl-5-pyrimidinyl)methyl)-5-(2- hydroxyethyl)-4-methylthiazolium chloride.

Which are Embriva UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Embriva Inactive Ingredients 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:

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Product Footnotes

[1] 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.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] 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.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".