Micronor
NDC Package 54868-4369-0

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

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

Micronor is 1. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4369 and is authorized under FDA application NDA016954.

Identification & Billing

NDC Package Code
54868-4369-0
Package Description
1 DIALPACK in 1 PACKAGE / 28 TABLET in 1 DIALPACK
Product Code
54868-4369
11-Digit Billing Format
54868436900
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Micronor
Dosage Form
-
Usage Information
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.

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
NDA016954
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-17-2003
Listing Expiration
12-31-2017
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-4369-0 identifies a specific commercial package of 1 dialpack in 1 package / 28 tablet in 1 dialpack of Micronor, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Physicians Total Care, Inc. on September 17, 2003. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868436900. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
54868-4369-0
11-Digit CMS (5-4-2)
54868-4369-00

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.