NDC 0378-7303 Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate

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

Product Information

NDC Product Code:
0378-7303
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]
Mylan Pharmaceuticals Inc.
Labeler Code:
0378
FDA Application Number: [6]
ANDA205069
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
07-27-2022
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
PURPLE (C48327 - LIGHT PURPLE)
PURPLE (C48327)
BROWN (C48332)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
242
243
244
291
Score:
1

Product Packages

NDC Code 0378-7303-53

Package Description: 3 POUCH in 1 CARTON / 1 BLISTER PACK in 1 POUCH (0378-7303-85) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (0378-7191-71) * 9 TABLET in 1 BLISTER PACK (0378-7192-59) * 7 TABLET in 1 BLISTER PACK (0378-7193-71) * 5 TABLET in 1 BLISTER PACK (0378-7190-98)

Price per Unit: $1.01247 per EA

Product Details

What is NDC 0378-7303?

The NDC code 0378-7303 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 Mylan Pharmaceuticals Inc.. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0378-7303-53 3 pouch in 1 carton / 1 blister pack in 1 pouch (0378-7303-85) / 1 kit in 1 blister pack * 7 tablet in 1 blister pack (0378-7191-71) * 9 tablet in 1 blister pack (0378-7192-59) * 7 tablet in 1 blister pack (0378-7193-71) * 5 tablet in 1 blister pack (0378-7190-98). 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 tablets and ferrous fumarate tablets are indicated for the prevention of pregnancy in women who elect to use combined oral contraceptives as a method of contraception. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets are indicated for the treatment of moderate acne vulgaris in females, ≥ 15 years of age, who have no known contraindications to combined oral contraceptive therapy, desire oral contraception, have achieved menarche, and are unresponsive to topical anti-acne medications. Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets should be used for the treatment of acne only if the patient desires a combined oral contraceptive for birth control and plans to stay on it for at least 6 months.Combined oral contraceptives are highly effective for pregnancy prevention. Table 2 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 2. Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year. United States.Emergency Contraceptives Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.èLactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. ðSource: Trussell J, The Essentials of Contraception. In Hatcher RA, Trussell J, Stewart F, Cates W, Stweart GK, Kowel D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.% of Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use at One Year‡Method(1)Typical Use*(2)Perfect Use†(3)(4)Chance§8585Spermicides¶26640Periodic Abstinence2563   Calendar9   Ovulation Method3   Symptothermal#Þ2   Post-ovulation1Capß   Parous Women402642   Nulliparous Women20956Sponge   Parous Women402042   Nulliparous Women20956Diaphragmß20656Withdrawal194Condomà   Female (Reality®)21556   Male14361Pill571   Progestin only0.5   Combined0.1IUD   Progesterone T2.01.581   Copper T380A0.80.678   LNG 200.10.181Depo-Provera®0.30.370Norplant® and   Norplant-2®0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100 ‡ Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year. * Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. † Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason. § The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within one year. This estimate was lowered slightly (to 85%) to represent the percent who would become pregnant within one year among women now relying on reversible methods of contraception if they abandoned contraception altogether.¶ Foams, creams, gels, vaginal suppositories, and vaginal film. #Þ Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.ß With spermicidal cream or jelly.à Without spermicides. è The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of combined oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse® (1 dose is 5 pink pills), Nordette® or Levlen® (1 dose is 4 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills). ð However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets were evaluated for the treatment of acne vulgaris in two randomized, double-blind, placebo-controlled, multicenter, Phase 3, six (28-day) cycle studies. A total of 296 patients received norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and 295 received placebo. Mean age at enrollment for both groups was 24 years. At six months each study demonstrated a statistically significant difference between norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and placebo for mean change from baseline in lesion counts (see Table 3 and Figure 2). Each study also demonstrated overall treatment success in the investigator’s global evaluation. Patients with severe androgen excess were not studied.Table 3. Acne Vulgaris Indication Pooled Data 376-403 and 376-404 Observed Means at Six Months and at Baseline*Intent To Treat Population Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate TabletsN=296PlaceboN=295Difference in CountsBetween Norethindrone Acetate and Ethinyl Estradiol Tablets and Ferrous Fumarate Tablets and Placebo at Six Months (95% CI) †Number of LesionsCounts% reductionCounts% reductionINFLAMMATORY LESIONS Baseline Mean 2929Six Month Mean1452%1741%3 (±2)NON-INFLAMMATORY LESIONSBaseline Mean 4443Six Month Mean2738%3225%5 (±3.5)TOTAL LESIONSBaseline Mean 7472Six Month Mean4243%4932%7 (±5)*Numbers rounded to nearest integer†Limits for 95% Confidence Interval; not adjusted for baseline differencesNorethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets users who started with about 74 acne lesions had about 42 lesions after 6 months of treatment. Placebo users who started with about 72 acne lesions had about 49 lesions after the same duration of treatment.Figure 2. Mean Percent Reduction in Total Lesion Counts From Baseline to Each 28-Day Cycle and Mean Total Lesion Counts at Each Cycle Following Administration of Norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets and Placebo (Statistically significant differences were not found in both studies individually until cycle 6) 

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: 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: 1359130 - norethindrone acetate 1 MG / ethinyl estradiol 30 MCG Oral Tablet
  • RxCUI: 1359130 - ethinyl estradiol 0.03 MG / norethindrone acetate 1 MG Oral Tablet

* 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".