NDC Package 0904-6754-15 Sudogest 12 Hour

Pseudoephedrine Hcl Tablet, Film Coated, Extended Release Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

0904-6754-15

Package Description:

10 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Product Code:

0904-6754

Proprietary Name:

Sudogest 12 Hour

Non-Proprietary Name:

Pseudoephedrine Hcl

Substance Name:

Pseudoephedrine Hydrochloride

Usage Information:

Pseudoephedrine is used for the temporary relief of stuffy nose and sinus pain/pressure caused by infection (such as the common cold, flu) or other breathing illnesses (such as hay fever, allergies, bronchitis). Pseudoephedrine is a decongestant (sympathomimetic). It works by narrowing the blood vessels to decrease swelling and congestion. If you are self-treating with this medication, it is important to read the manufacturer's package instructions carefully so you know when to consult your doctor or pharmacist. (See also Precautions section.) Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Long-acting tablets/capsules are not recommended for use in children younger than 12 years. Do not use this pseudoephedrine product in children younger than 12 years unless specifically directed by the doctor. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

11-Digit NDC Billing Format:

00904675415

Billing Unit:

EA - Billing unit of "each" is used when the product is dispensed in discreet units.

NDC to RxNorm Crosswalk:

10 EA

NDC to RxNorm Crosswalk:

RxCUI: 1049154 - pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet

RxCUI: 1049154 - 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet

RxCUI: 1049154 - pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet

RxCUI: 1049156 - SudoGest 120 MG 12HR Extended Release Oral Tablet

RxCUI: 1049156 - 12 HR pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Sudogest]

Product Type:

Human Otc Drug

Labeler Name:

Major Pharmaceuticals

Dosage Form:

Tablet, Film Coated, Extended Release - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer; the tablet is formulated in such manner as to make the contained medicament available over an extended period of time following ingestion.

Administration Route(s):

Oral - Administration to or by way of the mouth.

Active Ingredient(s):

PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1

Pharmacologic Class(es):

Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)

alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)

Sample Package:

FDA Application Number:

ANDA075153

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

02-12-2019

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

0904 - Major Pharmaceuticals
- 0904-6754 - Sudogest 12 Hour
  - 0904-6754-15 - 10 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

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 disclaimer below.

Frequently Asked Questions

What is NDC 0904-6754-15?

The NDC Packaged Code 0904-6754-15 is assigned to a package of 10 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack of Sudogest 12 Hour, a human over the counter drug labeled by Major Pharmaceuticals. The product's dosage form is tablet, film coated, extended release and is administered via oral form.

Is NDC 0904-6754 included in the NDC Directory?

Yes, Sudogest 12 Hour with product code 0904-6754 is active and included in the NDC Directory. The product was first marketed by Major Pharmaceuticals on February 12, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 0904-6754-15?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 10.

What is the 11-digit format for NDC 0904-6754-15?

The 11-digit format is 00904675415. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0904-6754-15	5-4-2	00904-6754-15

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