Diphenhydramine Hcl
NDC Package 10544-166-15
Package Information
Diphenhydramine Hcl is diphenhydramine injection is an antihistamine used to treat life-threatening allergic reactions (anaphylaxis) along with epinephrine and other treatments. Marketed by Blenheim Pharmacal, Inc., this product is identified by NDC 10544-166 and is authorized under FDA application part341.
Identification & Billing
- RxCUI: 1049909 - diphenhydrAMINE HCl 25 MG Oral Capsule
- RxCUI: 1049909 - diphenhydramine hydrochloride 25 MG Oral Capsule
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 10544 - Blenheim Pharmacal, Inc.
- 10544-166 - Diphenhydramine Hcl
- 10544-166-15 - 15 CAPSULE in 1 BOTTLE, PLASTIC
- 10544-166 - Diphenhydramine Hcl
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 10544-166-15 identifies a specific commercial package of 15 capsule in 1 bottle, plastic of Diphenhydramine Hcl, labeled by Blenheim Pharmacal, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 15 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 Blenheim Pharmacal, Inc. on May 12, 2010. The current certification is valid through December 31, 2017.
What are the primary indications for this medication?
Diphenhydramine injection is an antihistamine used to treat life-threatening allergic reactions (anaphylaxis) along with epinephrine and other treatments. It is also used to relieve symptoms of household allergies, hay fever and the common cold when medication cannot be given by mouth. Common allergy symptoms relieved by antihistamines include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose and sneezing. It is also used to treat nausea, vomiting and dizziness caused by motion sickness when medication cannot be given by mouth. Diphenhydramine works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine). Diphenhydramine should not be used in newborns or premature infants because of an increased risk of side effects. It should not be used for common cold symptoms in children less than 6 years of age due to the risk of serious side effects, such as slow/shallow breathing. Cough-and-cold products have not been shown to be safe or effective in children younger than 6.
How is this Blenheim Pharmacal, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 10544016615. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 15 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.