Zovia 1/35 Kit
NDC Package 75907-087-28

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

Zovia 1/35 (ethynodiol diacetate and ethinyl estradiol tablets) kits is zovia 1/35 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. This formulation utilizes a kit delivery system. Marketed by Dr. Reddy�s Laboratories Inc., this product is identified by NDC 75907-087 and is authorized under FDA application ANDA209548.

Identification & Billing

NDC Package Code
75907-087-28
Package Description
1 BLISTER PACK in 1 PACKET / 1 KIT in 1 BLISTER PACK
Product Code
75907-087
11-Digit Billing Format
75907008728
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zovia 1/35
Non-Proprietary Name
Ethynodiol Diacetate And Ethinyl Estradiol Tablets
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Zovia 1/35 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives 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 and progestogen implants and injections, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.(A) Among 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.(B) Among 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.(C) Among couples attempting to avoid pregnancy, the percentage who continue to use a method for one year.(D) The 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.(E) Foams, creams, gels, vaginal suppositories, and vaginal film.(F) Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.(G) With spermicidal cream or jelly.(H) Without spermicides.(I) 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).(J) However, 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.

Regulatory & Marketing

Labeler Name
Dr. Reddy�s Laboratories Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA209548
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-01-2024
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 (75907-087). Click a package code to view its specific billing and regulatory data.

75907-087-62
6 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 75907-087-28 identifies a specific commercial package of 1 blister pack in 1 packet / 1 kit in 1 blister pack of Zovia 1/35, a human prescription drug labeled by Dr. Reddy�s Laboratories Inc.. This kit is formulated for 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 Dr. Reddy�s Laboratories Inc. on June 01, 2024. The current certification is valid through December 31, 2026.

How is this Dr. Reddy�s Laboratories Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 75907008728. 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)
75907-087-28
11-Digit CMS (5-4-2)
75907-0087-28

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