Camila
NDC Package 54868-4814-0

11-digit billing NDC: 54868481400 · Billing unit: EA · 28 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Camila is 1. Marketed by Physicians Total Care, Inc., this product is identified by NDC 54868-4814 and is authorized under FDA application ANDA076177.

Identification & Billing

NDC Package Code
54868-4814-0
Package Description
28 TABLET in 1 BLISTER PACK
Product Code
54868-4814
11-Digit Billing Format
54868481400
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
28 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Camila
Dosage Form
-
Usage Information
1. Indications:Progestin-only oral contraceptives are indicated for the prevention of pregnancy.2. Efficacy:If used perfectly, the first-year failure rate for progestin-only oral contraceptives is 0.5%. However, the typical failure rate is estimated to be closer to 5%, due to late or omitted pills. The following table lists the pregnancy rates for users of all major methods of contraception.Table 1 Comparison of reversible contraceptive methods: Percent of women experiencing a contraceptive failure (pregnancy) during the first year of use. Percent of women experiencinga pregnancy within the first year of useMethodAverage UsePerfect UseNo contraception8585Spermicides216Periodic abstinence201-9† Withdrawal194Cervical capsGiven birthNever given birth3618269Diaphragms186CondomsFemaleMale211253PillsProgestin-onlyCombined30.50.1IUDsProgesteroneCopper T 380A20.81.50.6Injectables0.30.3Implant0.090.09  Adapted with permission.**Hatcher RA, Trussel J, Stewart F, Stewart GK, Kowal D, Guest F, Cates W, Pollcar M. Contraceptive Technology 1994-1996. New York, NY: Irvington Publishers. 1994.†Depending on method (calendar, ovulation, symptom-thermal, post-ovulation).

Regulatory & Marketing

Labeler Name
Physicians Total Care, Inc.
FDA Application #
ANDA076177
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-19-2003
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 54868-4814-0 identifies a specific commercial package of 28 tablet in 1 blister pack of Camila, labeled by Physicians Total Care, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 28 billable units per package. 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 Physicians Total Care, Inc. on June 19, 2003. The current certification is valid through December 31, 2017.

How is this Physicians Total Care, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54868481400. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 28 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 (5-4-1)
54868-4814-0
11-Digit CMS (5-4-2)
54868-4814-00

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