Micronor
NDC 54868-4369

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-4369?
  5. Micronor Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Micronor is a NDA-approved product labeled by Physicians Total Care, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a green product. This product entry covers the primary NDC 54868-4369 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
54868-4369
Proprietary Name:
Micronor
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
6fea0c04-cfbc-4bd2-8a1f-fa3d5ed2a941
FDA Application Number: [6]
NDA016954
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
09-17-2003
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I

Product Characteristics

Color(s):
GREEN (C48329 - GREEN)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
ORTHO;0;35
Score:
1

Code Structure Chart

Product Details

What is NDC 54868-4369?

The NDC code 54868-4369 is assigned by the FDA to the product Micronor. This pharmaceutical product is labeled by Physicians Total Care, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 54868-4369-0. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

1. IndicationsProgestin-only oral contraceptives are indicated for the prevention of pregnancy.2. EfficacyIf used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. Table 1 lists the pregnancy rates for users of all major methods of contraception.Table 1: 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.% of Women Experiencing anUnintended Pregnancy within theFirst Year of Use% of WomenContinuing Use atOne Year*Method(1)Typical Use †(2)Perfect Use‡(3)(4)Chance#8585SpermicidesÞ26640Periodic abstinence2563  Calendar9  Ovulation Method3  Sympto-Thermalß2  Post-Ovulation1Capà  Parous Women402642  Nulliparous Women20956Sponge  Parous Women402042  Nulliparous Women20956Diaphragmà20656Withdrawal194Condomè  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 Sterilization0.150.10100Adapted from Hatcher et al, 1998, Ref. # 1.§  Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.¶Lactational Amenorrhea Method: LAM is highly effective, temporary method of contraception.Source: Trussell J, Contraceptive efficacy. In Hatcher RA, Trussell J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.*Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one 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 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 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 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-Levlen® (1 dose is 4 yellow pills).¶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 six months of age.#The percents 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.ÞFoams, creams, gels, vaginal suppositories, and vaginal film.ßCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.àWith spermicidal cream or jelly.èWithout spermicides.ORTHO MICRONOR® Tablets have not been studied for and are not indicated for use in emergency contraception.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".