Parlodel
NDC Package 30698-201-01

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

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

Parlodel is hypersensitivity to bromocriptine or to any of the excipients of Parlodel (bromocriptine mesylate), uncontrolled hypertension and sensitivity to any ergot alkaloids. Marketed by Validus Pharmaceuticals Llc, this product is identified by NDC 30698-201 and is authorized under FDA application NDA017962.

Identification & Billing

NDC Package Code
30698-201-01
Package Description
100 CAPSULE, GELATIN COATED in 1 BOTTLE
Product Code
30698-201
11-Digit Billing Format
30698020101
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Parlodel
Dosage Form
-
Usage Information
Hypersensitivity to bromocriptine or to any of the excipients of Parlodel (bromocriptine mesylate), uncontrolled hypertension and sensitivity to any ergot alkaloids. In patients being treated for hyperprolactinemia, Parlodel should be withdrawn when pregnancy is diagnosed (see PRECAUTIONS, Hyperprolactinemic States). In the event that Parlodel is reinstituted to control a rapidly expanding macroadenoma (see PRECAUTIONS, Hyperprolactinemic States) and a patient experiences a hypertensive disorder of pregnancy, the benefit of continuing Parlodel must be weighed against the possible risk of its use during a hypertensive disorder of pregnancy. When Parlodel is being used to treat acromegaly, prolactinoma, or Parkinson’s disease in patients who subsequently become pregnant, a decision should be made as to whether the therapy continues to be medically necessary or can be withdrawn. If it is continued, the drug should be withdrawn in those who may experience hypertensive disorders of pregnancy (including eclampsia, preeclampsia, or pregnancy-induced hypertension) unless withdrawal of Parlodel is considered to be medically contraindicated.The drug should not be used during the postpartum period in women with a history of coronary artery disease and other severe cardiovascular conditions unless withdrawal is considered medically contraindicated. If the drug is used in the postpartum period, the patient should be observed with caution.

Regulatory & Marketing

Labeler Name
Validus Pharmaceuticals Llc
FDA Application #
NDA017962
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-28-2014
Listing Expiration
12-31-2024
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (30698-201). Click a package code to view its specific billing and regulatory data.

30698-201-30
30 CAPSULE, GELATIN COATED in 1 BOTTLE

* 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 30698-201-01 identifies a specific commercial package of 100 capsule, gelatin coated in 1 bottle of Parlodel, labeled by Validus Pharmaceuticals Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 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 Validus Pharmaceuticals Llc on April 28, 2014. The current certification is valid through December 31, 2024.

How is this Validus Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 30698020101. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
30698-201-01
11-Digit CMS (5-4-2)
30698-0201-01

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