NDC 16714-155 Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate

Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
16714-155
Proprietary Name:
Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate
Non-Proprietary Name: [1]
Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Northstar Rx Llc
Labeler Code:
16714
FDA Application Number: [6]
ANDA213317
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
04-07-2021
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328)
PURPLE (C48327)
Shape:
OVAL (C48345)
Size(s):
8 MM
Imprint(s):
NUMBERSIGN
Score:
1

Product Packages

NDC Code 16714-155-03

Package Description: 3 CARTON in 1 CARTON / 1 BLISTER PACK in 1 CARTON (16714-155-01) / 1 KIT in 1 BLISTER PACK

Price per Unit: $0.72124 per EA

Product Details

What is NDC 16714-155?

The NDC code 16714-155 is assigned by the FDA to the product Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate which is a human prescription drug product labeled by Northstar Rx Llc. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 16714-155-03 3 carton in 1 carton / 1 blister pack in 1 carton (16714-155-01) / 1 kit in 1 blister pack. 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 Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate?

Norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules is indicated for use by females of reproductive age to prevent pregnancy [see Clinical Studies (14)]. The efficacy of norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules in women with a body mass index (BMI) of more than 35 kg/m2 has not been evaluated.

Which are Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate UNII Codes?

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

Which are Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate 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:

What is the NDC to RxNorm Crosswalk for Norethindrone Acetate And Ethinyl Estradiol, And Ferrous Fumarate?

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: 1421459 - ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Capsule
  • RxCUI: 1421459 - ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Capsule
  • RxCUI: 1421460 - ferrous fumarate 75 MG Oral Capsule
  • RxCUI: 1421461 - {24 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Capsule) / 4 (ferrous fumarate 75 MG Oral Capsule) } Pack
  • RxCUI: 1421461 - Eth estra-Noreth Ac 0.02-1 MG (24) Oral Capsule / Ferr fum 75 MG (4) Oral Capsule 28 Day Pack

* Please review the disclaimer below.

Patient Education

Estrogen and Progestin (Oral Contraceptives)


Oral contraceptives (birth-control pills) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive cells) from entering. Oral contraceptives are a very effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases. Some brands of oral contraceptives are also used to treat acne in certain patients. Oral contraceptives treat acne by decreasing the amounts of certain natural substances that can cause acne. Some oral contraceptives (Beyaz, Yaz) are also used to relieve the symptoms of premenstrual dysphoric disorder (physical and emotional symptoms that occur before the menstrual period each month) in women who have chosen to use an oral contraceptive to prevent pregnancy.
[Learn More]


Iron Supplements


Iron (ferrous fumarate, ferrous gluconate, ferrous sulfate) is used to treat or prevent anemia (a lower than normal number of red blood cells) when the amount of iron taken in from the diet is not enough. Iron is a mineral that is available as a dietary supplement. It works by helping the body to produce red blood cells.
[Learn More]


* Please review the disclaimer below.

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.

[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.

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

[6] 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.

[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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".