NDC 65862-940 Aurovela Fe 1/20

Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate Kit - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
65862-940
Proprietary Name:
Aurovela Fe 1/20
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]
Aurobindo Pharma Limited
Labeler Code:
65862
FDA Application Number: [6]
ANDA207505
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
06-16-2017
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
YELLOW (C48330 - LIGHT YELLOW TO YELLOW)
BROWN (C48332)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
S;64
S;57
Score:
1

Product Packages

NDC Code 65862-940-58

Package Description: 5 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK

NDC Code 65862-940-88

Package Description: 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (65862-940-87) / 1 KIT in 1 BLISTER PACK

Price per Unit: $0.14915 per EA

Product Details

What is NDC 65862-940?

The NDC code 65862-940 is assigned by the FDA to the product Aurovela Fe 1/20 which is a human prescription drug product labeled by Aurobindo Pharma Limited. The generic name of Aurovela Fe 1/20 is norethindrone acetate and ethinyl estradiol and ferrous fumarate. The product's dosage form is kit. The product is distributed in 2 packages with assigned NDC codes 65862-940-58 5 pouch in 1 carton / 1 blister pack in 1 pouch / 1 kit in 1 blister pack, 65862-940-88 3 pouch in 1 carton / 1 blister pack in 1 pouch (65862-940-87) / 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 Aurovela Fe 1/20?

Aurovela Fe 1/20 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE I LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD Adapted from RA Hatcher et al, Reference 7.* The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any other reason.** This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any other reason.*** N/A--Data not available.% of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use  MethodLowest Expected*Typical**  (No contraception)  Oral contraceptives       combined       progestin only  Diaphragm with spermicidal        cream or jelly   Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) Vaginal Sponge       nulliparous       parous  Implant  Injection: depot medroxyprogesterone acetate  IUD       progesterone T       copper T 380A       LNg 20  Condom without spermicides       female       male  Cervical Cap with spermicidal       cream or jelly       nulliparous        parous  Periodic abstinence (all methods)  Withdrawal  Female sterilization  Male sterilization(85) 0.10.5 669200.050.3 1.50.60.1 53  9261 to 940.50.1(85)3N/A***N/A*** 202620400.050.3 20.80.1 2114  204025190.50.15

Which are Aurovela Fe 1/20 UNII Codes?

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

Which are Aurovela Fe 1/20 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 Aurovela Fe 1/20?

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: 1358762 - norethindrone acetate 1 MG / ethinyl estradiol 0.02 MG Oral Tablet
  • RxCUI: 1358762 - ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1358762 - ethinyl estradiol 20 MCG / norethindrone acetate 1 MG Oral Tablet
  • RxCUI: 1358763 - {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) / 7 (ferrous fumarate 75 MG Oral Tablet) } Pack
  • RxCUI: 1358763 - Eth-estra-Noreth Ac 0.02-1 MG (21) Oral Tablet / Ferr fum 75 MG (7) Oral Tablet 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".