NDC Package 42494-441-25 Phenobarbital Sodium

Injection Intramuscular - 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:

42494-441-25

Package Description:

25 VIAL in 1 BOX, UNIT-DOSE / 1 mL in 1 VIAL

Product Code:

42494-441

Proprietary Name:

Phenobarbital Sodium

Non-Proprietary Name:

Phenobarbital Sodium

Substance Name:

Phenobarbital Sodium

Usage Information:

Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria, marked impairment of liver functions or with severe respiratory distress where dyspnea or obstruction is evident. Large doses are contraindicated in nephritic subjects.Barbiturates should not be administered to persons with known previous addiction to the sedative-hypnotic group since ordinary doses may be ineffectual and may contribute to further addiction.Intraarterial administration is contraindicated. Its consequences vary from transient pain to gangrene. Subcutaneous administration produces tissue irritation, ranging from tenderness and redness to necrosis and is not recommended. (See DOSAGE AND ADMINISTRATION, Treatment of Adverse Effects Due to Inadvertent Error in Administration.)Phenobarbital Sodium Injection contains the preservative benzyl alcohol and is not recommended for use in neonates. There have been reports of fatal 'gasping syndrome' in neonates (children less than one month of age) following the administration of intravenous solutions containing the preservative benzyl alcohol. Symptoms include a striking onset of gasping respiration, hypotension, bradycardia, and cardiovascular collapse.

11-Digit NDC Billing Format:

42494044125

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

NDC to RxNorm Crosswalk:

RxCUI: 198368 - PHENobarbital 65 MG/ML Injectable Solution

RxCUI: 198368 - phenobarbital 65 MG/ML Injectable Solution

RxCUI: 312370 - PHENobarbital 130 MG/ML Injectable Solution

RxCUI: 312370 - phenobarbital 130 MG/ML Injectable Solution

Product Type:

Human Prescription Drug

Labeler Name:

Cameron Pharmaceuticals

Dosage Form:

Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Administration Route(s):

Intramuscular - Administration within a muscle.

Active Ingredient(s):

PHENOBARBITAL SODIUM 65 mg/mL

DEA Schedule:

Schedule IV (CIV) Substances

Sample Package:

Marketing Category:

UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Start Marketing Date:

06-02-2023

Listing Expiration Date:

12-31-2024

Exclude Flag:

Code Structure:

42494 - Cameron Pharmaceuticals
- 42494-441 - Phenobarbital Sodium
  - 42494-441-25 - 25 VIAL in 1 BOX, UNIT-DOSE / 1 mL in 1 VIAL

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 42494-441-25?

The NDC Packaged Code 42494-441-25 is assigned to a package of 25 vial in 1 box, unit-dose / 1 ml in 1 vial of Phenobarbital Sodium, a human prescription drug labeled by Cameron Pharmaceuticals. The product's dosage form is injection and is administered via intramuscular form.

Is NDC 42494-441 included in the NDC Directory?

Yes, Phenobarbital Sodium with product code 42494-441 is active and included in the NDC Directory. The product was first marketed by Cameron Pharmaceuticals on June 02, 2023 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 42494-441-25?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 42494-441-25?

The 11-digit format is 42494044125. 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 5-3-2 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
5-3-2	42494-441-25	5-4-2	42494-0441-25

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