NDC 76413-150 Pirmella 7/7/7

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
76413-150
Proprietary Name:
Pirmella 7/7/7
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
76413
Start Marketing Date: [9]
05-15-2013
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
PINK (C48328 - LIGHT PEACH)
PINK (C48328 - PEACH)
GREEN (C48329 - GREEN)
Shape:
ROUND (C48348)
Size(s):
6 MM
Imprint(s):
LU;L23
LU;L24
LU;L25
LU;L27
Score:
1

Code Structure Chart

Product Details

What is NDC 76413-150?

The NDC code 76413-150 is assigned by the FDA to the product Pirmella 7/7/7 which is product labeled by Central Texas Community Health Centers. The product's dosage form is . The product is distributed in a single package with assigned NDC code 76413-150-28 3 blister pack in 1 carton / 1 kit in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Pirmella 7/7/7?

Pirmella 7/7/7 and Pirmella 1/35 Tablets are 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 1 lists the typical accidental pregnancy rates for users of combined 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.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 Experiencingan Unintended Pregnancywithin the First Year of Use% of Women ContinuingUse at One YearAmong couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.Method(1)Typical UseAmong 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.(2)Perfect UseAmong 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.(3)(4)ChanceThe 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.8585SpermicidesFoams, creams, gels, vaginal suppositories, and vaginal film.26640Periodic abstinence2563    Calendar9    Ovulation Method3    Sympto-ThermalCervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.2    Post-Ovulation1CapWith spermicidal cream or jelly.    Parous Women402642    Nulliparous Women20956Sponge    Parous Women402042    Nulliparous Women20956Diaphragm20656Withdrawal194CondomWithout spermicides.    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%.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).Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception.0Pirmella 7/7/7 and Pirmella 1/35 have not been studied for and are not indicated for use in emergency contraception.

Which are Pirmella 7/7/7 UNII Codes?

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

Which are Pirmella 7/7/7 Inactive Ingredients 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 Pirmella 7/7/7?

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:
  • RxCUI: 1427301 - {7 (ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 0.75 MG Oral Tablet) / 7 (ethinyl estradiol 0.035 MG / norethindrone 1 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Pirmella 7/7/7 28 Day]
  • RxCUI: 1427301 - Pirmella 7/7/7 28 Day Pack
  • RxCUI: 310463 - norethindrone 0.5 MG / ethinyl estradiol 0.035 MG Oral Tablet
  • RxCUI: 310463 - ethinyl estradiol 0.035 MG / norethindrone 0.5 MG Oral Tablet
  • RxCUI: 310463 - ethinyl estradiol 35 MCG / norethindrone 0.5 MG Oral Tablet

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".