Philith Kit
NDC 16714-347

Kit (oral)
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 16714-347?
  5. Philith Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

Philith (norethindrone and ethinyl estradiol tablets) is a ANDA-approved product labeled by Northstar Rx Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit for oral administration. This product entry covers the primary NDC 16714-347 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
16714-347
Proprietary Name:
Philith
Non-Proprietary Name: [1]
Norethindrone And Ethinyl Estradiol Tablets
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Northstar Rx Llc
Labeler Code:
16714
Product Label ID:
77b8d3ef-f3ac-4148-84f0-f6cb327c9f78
FDA Application Number: [6]
ANDA090947
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-22-2011
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
PHILITH: BROWN (C48332 - TAN)
INERT: WHITE (C48325)
Shape:
PHILITH: ROUND (C48348)
INERT: ROUND (C48348)
Size(s):
PHILITH: 5 MM
INERT: 5 MM
Imprint(s):
PHILITH: C35
INERT: P;N
Score:
OTHER
PHILITH: 1
INERT: 1

Code Structure Chart

Product Details

What is NDC 16714-347?

The NDC code 16714-347 is assigned by the FDA to the product Philith. It is commonly known by its generic name, norethindrone and ethinyl estradiol tablets. This pharmaceutical product is labeled by Northstar Rx Llc and is currently categorized as listed product. The medication is a kit administered via oral route. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 16714-347-01, 16714-347-02, 16714-347-03, 16714-347-04. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

 Oral contraceptives 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 combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.TABLE 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD% of Women Experiencing an Accidental Pregnancy in the First Year of Continuous UseMethodLowest Expected*Typical**(No contraception)(85)(85)Oral contraceptivescombinedprogestin only0.10.53***3***Diaphragm with spermicidal cream or jelly618Spermicides alone (foam, creams, jellies and vaginal suppositories)321Vaginal spongenulliparousmultiparous691828IUD0.8-2.03#Condom without spermicides212Periodic abstinence (all methods)1-920Injectable progestogen0.3-0.40.3-0.4Implants6 capsules2 rods0.040.030.040.03Female sterilization0.20.4Male sterilization0.10.15Reproduced with permission of the Population Council from J. Trussell, et. al: Contraceptive failure in the United States: An update. Studies in Family Planning, 21(1), January-February 1990.*The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any reason other than pregnancy.**This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any reason other than pregnancy.***Combined typical rate for both combined and progestin only.#Combined typical rate for both medicated and nonmedicated IUD.

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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: 1235874 - {21 (ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet) / 7 (inert ingredients 1 MG Oral Tablet) } Pack [Philith 28 Day]
  • RxCUI: 1235874 - PHILITH 28 Day Pack
  • RxCUI: 1235874 - Philith 28 Day Pack
  • RxCUI: 238015 - norethindrone 0.4 MG / ethinyl estradiol 0.035 MG Oral Tablet
  • RxCUI: 238015 - ethinyl estradiol 0.035 MG / norethindrone 0.4 MG Oral Tablet

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

Patient Education

Estrogen and Progestin (Oral Contraceptives)


Oral contraceptives (birth-control pills) are used to prevent pregnancy. Estrogen and progestin are two female sex hormones. Combinations of estrogen and progestin work by preventing ovulation (the release of eggs from the ovaries). They also change the lining of the uterus (womb) to prevent pregnancy from developing and change the mucus at the cervix (opening of the uterus) to prevent sperm (male reproductive cells) from entering. Oral contraceptives are a very effective method of birth control, but they do not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) and other sexually transmitted diseases. Some brands of oral contraceptives are also used to treat acne in certain patients. Oral contraceptives treat acne by decreasing the amounts of certain natural substances that can cause acne. Some oral contraceptives (Beyaz, Yaz) are also used to relieve the symptoms of premenstrual dysphoric disorder (physical and emotional symptoms that occur before the menstrual period each month) in women who have chosen to use an oral contraceptive to prevent pregnancy.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".