Diphenhydramine Hydrochloride Tablet
NDC Package 68094-018-61

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

Package Information

Diphenhydramine Hydrochloride tablets is use as directed per healthcare professional.take every 4 to 6 hours, or as directed by a doctordo not take more than 6 doses in 24 hoursadults and children 12 years and over1 to 2 tabletschildren 6 to under 12 years1 tabletchildren under 6 yearsdo not use. This formulation utilizes a tablet delivery system. Marketed by Precision Dose, Inc., this product is identified by NDC 68094-018 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
68094-018-61
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK (68094-018-59)
Product Code
68094-018
11-Digit Billing Format
68094001861
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Diphenhydramine Hydrochloride
Non-Proprietary Name
Diphenhydramine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
DIPHENHYDRAMINE HYDROCHLORIDE 25 mg/1
Pharmacologic Class
Usage Information
Use as directed per healthcare professional.take every 4 to 6 hours, or as directed by a doctordo not take more than 6 doses in 24 hoursadults and children 12 years and over1 to 2 tabletschildren 6 to under 12 years1 tabletchildren under 6 yearsdo not use

Regulatory & Marketing

Labeler Name
Precision Dose, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-15-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 68094-018-61 identifies a specific commercial package of 10 blister pack in 1 carton / 10 tablet in 1 blister pack (68094-018-59) of Diphenhydramine Hydrochloride, a human over the counter drug labeled by Precision Dose, Inc.. This tablet 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 Precision Dose, Inc. on July 15, 2019. The current certification is valid through December 31, 2026.

How is this Precision Dose, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68094001861. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 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:

10-Digit Format (5-3-2)
68094-018-61
11-Digit CMS (5-4-2)
68094-0018-61

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