55045-3683 NDC - DIPHENHYDRAMINE HYDROCHLORIDE ()

Drug Information

  • Product NDC: 55045-3683
  • Proprietary Name: Diphenhydramine Hydrochloride
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Dispensing Solutions, Inc.
Product Type:
FDA Application Number: ANDA080817
Marketing Category: ANDA
Start Marketing Date:11/27/1972

Package Information

No. Package Code Package Description Billing Unit
155045-3683-125 VIAL in 1 PACKAGE (55045-3683-1) / 1 mL in 1 VIAL

NDC Record

Field Name Field Value Definition
PRODUCT NDC55045-3683The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEDiphenhydramine HydrochlorideThe labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
START MARKETING DATE11/27/1972This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
APPLICATION NUMBERANDA080817The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
LABELER NAMEDispensing Solutions, Inc.The translation of the route code submitted by the firm, indicating route of administration.

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This page was last updated on: 11/21/2025