67046-1036 NDC - HYDROXYZINE HYDROCHLORIDE ()

Drug Information

  • Product NDC: 67046-1036
  • Proprietary Name: Hydroxyzine Hydrochloride
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Coupler LLC
Product Type:
FDA Application Number: ANDA088617
Marketing Category: ANDA
Start Marketing Date:11/12/2024

Package Information

No. Package Code Package Description Billing Unit
167046-1036-330 TABLET, FILM COATED in 1 BLISTER PACK (67046-1036-3)

NDC Record

Field Name Field Value Definition
PRODUCT NDC67046-1036The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAMEHydroxyzine HydrochlorideThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE11/12/2024This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
APPLICATION NUMBERANDA088617Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAMECoupler LLCName of Company corresponding to the labeler code segment of the Product NDC.

Download Record

Download this NDC record record in Text format: Export

Download this NDC record record in Excel (CSV) format: Export

Download this NDC record record in XML format: Export

This page was last updated on: 1/2/2026

Previous Code
Next Code