NDC Package 61010-4409-1 Diphenhydramine

View Billable Units, 11-Digit Format, RxNorm

Package Information
Other Packages
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:

61010-4409-1

Package Description:

50 POUCH in 1 BOX / 2 CAPSULE in 1 POUCH (61010-4409-0)

Product Code:

61010-4409

Proprietary Name:

Diphenhydramine

Usage Information:

Take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12 years and over 1 to 2 capsules children 6 to under 12 years 1 capsule children under 6 years do not use

11-Digit NDC Billing Format:

61010440901

NDC to RxNorm Crosswalk:

RxCUI: 1049909 - diphenhydrAMINE HCl 25 MG Oral Capsule
RxCUI: 1049909 - diphenhydramine hydrochloride 25 MG Oral Capsule

Labeler Name:

Safetec Of America, Inc.

Sample Package:

FDA Application Number:

part341

Marketing Category:

OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Start Marketing Date:

12-30-2019

Listing Expiration Date:

12-31-2022

Exclude Flag:

Code Structure:

61010 - Safetec Of America, Inc.
- 61010-4409 - Diphenhydramine
  - 61010-4409-1 - 50 POUCH in 1 BOX / 2 CAPSULE in 1 POUCH (61010-4409-0)

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.

Other Product Packages

The following packages are also available for this product:

NDC Package Code	Package Description
61010-4409-0	2 CAPSULE in 1 POUCH
61010-4409-2	100 POUCH in 1 BOX / 2 CAPSULE in 1 POUCH (61010-4409-0)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 61010-4409-1?

The NDC Packaged Code 61010-4409-1 is assigned to a package of 50 pouch in 1 box / 2 capsule in 1 pouch (61010-4409-0) of Diphenhydramine, labeled by Safetec Of America, Inc.. The product's dosage form is and is administered via form.

Is NDC 61010-4409 included in the NDC Directory?

No, Diphenhydramine with product code 61010-4409 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Safetec Of America, Inc. on December 30, 2019 and its listing in the NDC Directory is set to expire on December 31, 2022 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 61010-4409-1?

The 11-digit format is 61010440901. 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 5-4-1 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
5-4-1	61010-4409-1	5-4-2	61010-4409-01

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