Philith Kit
NDC Package 16714-347-04

11-digit billing NDC: 16714034704 · Billing unit: EA · 6 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Philith (norethindrone and ethinyl estradiol tablets) kits is  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. This formulation utilizes a kit delivery system. Marketed by Northstar Rx Llc, this product is identified by NDC 16714-347 and is authorized under FDA application ANDA090947.

Identification & Billing

NDC Package Code
16714-347-04
Package Description
6 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
16714-347
11-Digit Billing Format
16714034704
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
6 EA
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Philith
Non-Proprietary Name
Norethindrone And Ethinyl Estradiol Tablets
Dosage Form
Kit - A packaged collection of related material.
Administration Route
Oral - Administration to or by way of the mouth.
Usage Information
 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.

Regulatory & Marketing

Labeler Name
Northstar Rx Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA090947
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
12-22-2011
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (16714-347). Click a package code to view its specific billing and regulatory data.

16714-347-01
1 BLISTER PACK in 1 PACKET / 1 KIT in 1 BLISTER PACK
16714-347-02
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
16714-347-03
3 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK

* 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 16714-347-04 identifies a specific commercial package of 6 blister pack in 1 carton / 1 kit in 1 blister pack of Philith, a human prescription drug labeled by Northstar Rx Llc. This kit is formulated for oral use and contains 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 Northstar Rx Llc on December 22, 2011. The current certification is valid through December 31, 2026.

How is this Northstar Rx Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 16714034704. 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)
16714-347-04
11-Digit CMS (5-4-2)
16714-0347-04

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