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  4. NDC Product Code: 53002-1549 Microgestin 1/20

NDC 53002-1549 Microgestin 1/20

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 53002-1549?
  5. Microgestin 1/20 Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
53002-1549
Proprietary Name:
Microgestin 1/20
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Rpk Pharmaceuticals, Inc.
Labeler Code:
53002
Product Label ID:
f59e9f71-9074-42f9-9ffa-8a3172fb1f6c
Start Marketing Date: [9]
08-05-2016
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
P;D;915
Score:
1

Product Packages

NDC Code 53002-1549-1

Package Description: 1 BLISTER PACK in 1 PACKAGE / 1 TABLET in 1 BLISTER PACK

NDC Code 53002-1549-3

Package Description: 3 BLISTER PACK in 1 PACKAGE / 1 TABLET in 1 BLISTER PACK

NDC Code 53002-1549-6

Package Description: 6 BLISTER PACK in 1 PACKAGE / 1 TABLET in 1 BLISTER PACK

Product Details

What is NDC 53002-1549?

The NDC code 53002-1549 is assigned by the FDA to the product Microgestin 1/20 which is product labeled by Rpk Pharmaceuticals, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 53002-1549-1 1 blister pack in 1 package / 1 tablet in 1 blister pack, 53002-1549-3 3 blister pack in 1 package / 1 tablet in 1 blister pack, 53002-1549-6 6 blister pack in 1 package / 1 tablet 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 Microgestin 1/20?

MICROGESTIN and MICROGESTIN Fe are 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  % Of Women Experiencing an Unintended Pregnancy in the First Year of Continuous Use    Lowest    Method   Expected*  Typical**  (No contraception) ......................   (85)  (85)  Oral contraceptives ....................  3     combined ................................   0.1  N/A***     progestin only ........................   0.5  N/A***  Diaphragm with spermicidal cream or jelly ..............................  6  20  Spermicides alone (foam, creams, gels, vaginal suppositories, and vaginal film) ................................   6  26  Vaginal Sponge         nulliparous ..............................   9  20     parous ....................................   20  40  Implant........................................   0.05  0.05  Injection: depot medroxyprogesterone acetate ....................................  0.3  0.3  IUD         progesterone T ........................   1.5  2.0     copper T 380A ........................  0.6  0.8     LNg 20 ....................................   0.1  0.1  Condom without spermicides         female......................................   5  21     male ........................................  3  14  Cervical Cap with spermicidal cream or jelly         nulliparous ..............................   9  20     parous ....................................   26  40  Periodic abstinence (all methods) ..............................  1-9  25  Withdrawal..................................  4  19  Female sterilization......................  0.5  0.5  Male sterilization ........................   0.10  0.15  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.

Which are Microgestin 1/20 UNII Codes?

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

Which are Microgestin 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 Microgestin 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: 1358776 - {21 (ethinyl estradiol 0.02 MG / norethindrone acetate 1 MG Oral Tablet) } Pack
  • RxCUI: 1358776 - Eth estra-Noreth Ac 0.02-1 MG (21) Oral Tablet 21 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.
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* Please review the disclaimer below.

Product Footnotes

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

[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".