Pirmella 1/35
NDC Package 68180-893-73

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Pirmella 1/35 is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.Oral contraceptives are highly effective. Marketed by Lupin Pharmaceuticals, Inc., this product is identified by NDC 68180-893 and is authorized under FDA application ANDA201512.

Identification & Billing

NDC Package Code
68180-893-73
Package Description
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (68180-893-71)
Product Code
68180-893
11-Digit Billing Format
68180089373
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
3 EA
RxNorm Crosswalk
  • RxCUI: 1427300 - {21 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Pirmella 1/35 28 Day]
  • RxCUI: 1427300 - Pirmella 1/35 28 Day Pack
  • RxCUI: 312033 - norethindrone acetate 1 MG / ethinyl estradiol 35 MCG Oral Tablet
  • RxCUI: 312033 - ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet
  • RxCUI: 312033 - ethinyl estradiol 35 MCG / norethindrone 1 MG Oral Tablet

Clinical Specifications

Proprietary Name
Pirmella 1/35
Dosage Form
-
Usage Information
Pirmella 1/35 is indicated for the prevention of pregnancy in women who elect to use this product 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, the IUD, and the NORPLANT® System depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.Source: Trussel J, Contraceptive efficacy. In Hatcher RA, Trussel J, Stewart F, Cates W, Stewart GK, Kowal D, Guest F, Contraceptive Technology: Seventeenth Revised Edition. New York NY: Irvington Publishers, 1998.1Among 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.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 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.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 2 light-orange pills), Lo/Ovral® (1 dose is 4 white pills), Triphasil® or Tri-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 six months of age.Table I: 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 Year3Method(1)Typical Use1(2)Perfect Use2(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     Combined0.1IUD     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%.9Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.10

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals, Inc.
FDA Application #
ANDA201512
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-28-2013
End Marketing Date
09-30-2021
Listing Expiration
09-30-2021
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68180-893). Click a package code to view its specific billing and regulatory data.

68180-893-13
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK (68180-893-11)

* 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 68180-893-73 identifies a specific commercial package of 3 blister pack in 1 carton / 1 kit in 1 blister pack (68180-893-71) of Pirmella 1/35, labeled by Lupin Pharmaceuticals, 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 Lupin Pharmaceuticals, Inc. on June 28, 2013. The current certification is valid through September 30, 2021.

How is this Lupin Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68180089373. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 3 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)
68180-893-73
11-Digit CMS (5-4-2)
68180-0893-73

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