Nora Be
NDC Package 52544-629-28

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 discontinued by the firm.

Nora Be is 1. Marketed by Actavis Pharma, Inc., this product is identified by NDC 52544-629 and is authorized under FDA application NDA017060.

Identification & Billing

NDC Package Code
52544-629-28
Package Description
6 PACKAGE in 1 CARTON / 28 TABLET in 1 PACKAGE
Product Code
52544-629
11-Digit Billing Format
52544062928
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6 EA

Clinical Specifications

Proprietary Name
Nora Be
Dosage Form
-
Usage Information
1. Indications. Progestin-only oral contraceptives are indicated for the prevention of pregnancy.2. Efficacy. If 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. The following table lists the pregnancy rates for users of all major methods of contraception.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.  % of WomenExperiencing anUnintended Pregnancywithin the FirstYear of Use % of WomenContinuingUse atOne Year3 Method(1) Typical Use1(2) Perfect Use2(3) (4) Chance4 85 85  Spermicides5 26 6 40 Periodic abstinence 25  63    Calendar  9     Ovulation Method  3     Sympto-Thermal6  2     Post-Ovulation  1  Cap7       Parous Women 40 26 42    Nulliparous Women 20 9 56 Sponge       Parous Women 40 20 42    Nulliparous Women 20 9 56 Diaphragm7 20 6 56 Withdrawal 19 4  Condom8       Female (Reality) 21 5 56    Male 14 3 61 Pill 5  71    Progestin only  0.5     Combined  0.1  IUDs       Progesterone T 2.0 1.5 81    Copper T380A 0.8 0.6 78    LNg 20 0.1 0.1 81 Depo-Provera® 0.3 0.3 70 Levonorgestrel Implants   (Norplant®) 0.05 0.05 88 Female Sterilization 0.5 0.5 100 Male Sterilization 0.15 0.10 100Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%.9Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10Source: 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 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 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.Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.The percentage of women becoming pregnant noted 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 percentage that 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.Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.With spermicidal cream or jelly.Without spermicides.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 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 6 months of age.

Regulatory & Marketing

Labeler Name
Actavis Pharma, Inc.
FDA Application #
NDA017060
Marketing Category
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date
05-12-2005
End Marketing Date
06-30-2026
Listing Expiration
06-30-2026
Exclude Flag
D
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 52544-629-28 identifies a specific commercial package of 6 package in 1 carton / 28 tablet in 1 package of Nora Be, labeled by Actavis Pharma, Inc.. 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 Actavis Pharma, Inc. on May 12, 2005. The current certification is valid through June 30, 2026.

How is this Actavis Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52544062928. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 6 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 (5-3-2)
52544-629-28
11-Digit CMS (5-4-2)
52544-0629-28

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