Promethazine Hydrochloride Syrup
NDC Package 27808-051-01

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

Promethazine Hydrochloride syrups is promethazine Hydrochloride Syrup (Promethazine Hydrochloride Oral Solution, USP) is useful for:Perennial and seasonal allergic rhinitis.Vasomotor rhinitis.Allergic conjunctivitis due to inhalant allergens and foods.Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.Amelioration of allergic reactions to blood or plasma.Dermographism.Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.Preoperative, postoperative, or obstetric sedation.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.Active and prophylactic treatment of motion sickness.Antiemetic therapy in postoperative patients. This formulation utilizes a syrup delivery system. Marketed by Cranbury Pharmaceuticals, Llc, this product is identified by NDC 27808-051 and is authorized under FDA application ANDA091675.

Identification & Billing

NDC Package Code
27808-051-01
Package Description
237 mL in 1 BOTTLE
Product Code
27808-051
11-Digit Billing Format
27808005101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Promethazine Hydrochloride
Non-Proprietary Name
Promethazine Hydrochloride
Substance Name
Promethazine Hydrochloride
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL
Pharmacologic Class
Usage Information
Promethazine Hydrochloride Syrup (Promethazine Hydrochloride Oral Solution, USP) is useful for:Perennial and seasonal allergic rhinitis.Vasomotor rhinitis.Allergic conjunctivitis due to inhalant allergens and foods.Mild, uncomplicated allergic skin manifestations of urticaria and angioedema.Amelioration of allergic reactions to blood or plasma.Dermographism.Anaphylactic reactions, as adjunctive therapy to epinephrine and other standard measures, after the acute manifestations have been controlled.Preoperative, postoperative, or obstetric sedation.Prevention and control of nausea and vomiting associated with certain types of anesthesia and surgery.Therapy adjunctive to meperidine or other analgesics for control of postoperative pain.Sedation in both children and adults, as well as relief of apprehension and production of light sleep from which the patient can be easily aroused.Active and prophylactic treatment of motion sickness.Antiemetic therapy in postoperative patients.

Regulatory & Marketing

Labeler Name
Cranbury Pharmaceuticals, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA091675
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-08-2012
End Marketing Date
03-01-2027
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 (27808-051). Click a package code to view its specific billing and regulatory data.

27808-051-02
473 mL 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 27808-051-01 identifies a specific commercial package of 237 ml in 1 bottle of Promethazine Hydrochloride, a human prescription drug labeled by Cranbury Pharmaceuticals, Llc. This syrup is formulated for oral use and contains promethazine hydrochloride 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 Cranbury Pharmaceuticals, Llc on June 08, 2012.

How is this Cranbury Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 27808005101. 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)
27808-051-01
11-Digit CMS (5-4-2)
27808-0051-01

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