Norethindrone Tablet
NDC Package 82804-175-28

11-digit billing NDC: 82804017528 · Billing unit: EA · 28 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Norethindrone tablets is 1. This formulation utilizes a tablet delivery system. Marketed by Proficient Rx Lp, this product is identified by NDC 82804-175 and is authorized under FDA application ANDA091325.

Identification & Billing

NDC Package Code
82804-175-28
Package Description
1 BLISTER PACK in 1 BAG / 28 TABLET in 1 BLISTER PACK
Product Code
82804-175
11-Digit Billing Format
82804017528
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Norethindrone
Non-Proprietary Name
Norethindrone
Substance Name
Norethindrone
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
NORETHINDRONE .35 mg/1
Pharmacologic Class
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 Women Experiencing an Unintended Pregnancy within the First Year of Use% of Women Continuing Use at One Year31Among 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.2Among 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.3Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.4The 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.5Foams, creams, gels, vaginal suppositories, and vaginal film.6Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.7With spermicidal cream or jelly.8Without spermicides.9The 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).10However, 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.MethodTypical Use1Perfect Use2(1)(2)(3)(4)Chance48585Spermicides526640Periodic abstinence2563           Calendar9           Ovulation Method3           Sympto-Thermal62           Post-Ovulation1Cap7           Parous Women402642           Nulliparous Women20956Sponge           Parous Women402042           Nulliparous Women20956Diaphragm720656Withdrawal194Condom8           Female (Reality)21556           Male14361Pill571           Progestin only0.5           Combined0.1IUDs           Progesterone T2.01.581           Copper T380A0.80.678           LNg 200.10.181Depo-Provera®0.30.370Levonorgestrel Implants (Norplant®)0.050.0588Female Sterilization0.50.5100Male Sterilization0.150.10100Emergency 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.

Regulatory & Marketing

Labeler Name
Proficient Rx Lp
Product Type
Human Prescription Drug
FDA Application #
ANDA091325
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-11-2020
Listing Expiration
12-31-2027
Exclude Flag
N
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 82804-175-28 identifies a specific commercial package of 1 blister pack in 1 bag / 28 tablet in 1 blister pack of Norethindrone, a human prescription drug labeled by Proficient Rx Lp. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package. This tablet is formulated for oral use and contains norethindrone as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Proficient Rx Lp on November 11, 2020. The current certification is valid through December 31, 2027.

How is this Proficient Rx Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82804017528. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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)
82804-175-28
11-Digit CMS (5-4-2)
82804-0175-28

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