Diphenhydramine Hydrochloride Solution
NDC Package 0121-0489-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Diphenhydramine Hydrochloride solution is diphenhydramine hydrochloride in the oral form is effective for the following indications:. This formulation utilizes a solution delivery system. Marketed by Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-0489 and is authorized under FDA application ANDA087513.

Identification & Billing

NDC Package Code
0121-0489-00
Package Description
10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0489-05)
Product Code
0121-0489
11-Digit Billing Format
00121048900
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1049906 - diphenhydrAMINE HCl 12.5 MG in 5 mL Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 2.5 MG/ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine HCl 12.5 MG per 5 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 25 MG per 10 ML Oral Solution
  • RxCUI: 1049906 - diphenhydramine hydrochloride 50 MG per 20 ML Oral Solution

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloride
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
Pharmacologic Class
Usage Information
Diphenhydramine hydrochloride in the oral form is effective for the following indications:

Regulatory & Marketing

Labeler Name
Pai Holdings, Llc Dba Pai Pharma
Product Type
Human Prescription Drug
FDA Application #
ANDA087513
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-10-1982
Listing Expiration
12-31-2026
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.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

Q0163
Source: PDAC
DIPHENHYDRAMINE HYDROCHLORIDE, 50 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT TIME OF CHEMOTHERAPY TREATMENT NOT TO EXCEED A 48 HOUR DOSAGE REGIMEN
HCPCS Dosage 50 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* 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 0121-0489-00 identifies a specific commercial package of 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose (0121-0489-05) of Diphenhydramine Hydrochloride, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. This solution is formulated for oral use and contains diphenhydramine 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 Pai Holdings, Llc Dba Pai Pharma on February 10, 1982. The current certification is valid through December 31, 2026.

How is this Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121048900. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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 (4-4-2)
0121-0489-00
11-Digit CMS (5-4-2)
00121-0489-00

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