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Animal NDC 86117-050-07 Acepromazine Maleate

Animal Product Information

Field Name Field Value
Animal NDC Code 86117-050-07
Proprietary Name Acepromazine Maleate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Acepromazine Maleate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zyvet Animal Health Inc.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Acepromazine Maleate
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product 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.
FDA Application Number ANADA200757 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Acepromazine Maleate Images

Acepromazine Maleate Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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Manufactured by:
Zydus Animal Health and Investments Limited, Ahmedabad, India.


Distributed by:
ZyVet Animal Health Inc.
Pennington, NJ 08534


Principal Display Panel - Bottle Label, 10 Mg – 100 Tablets



NDC 86117-049-07

Acepromazine

Maleate Tablets

10 mg

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Approved by FDA under ANADA # 200-757

Net Contents:

100 Tablets


Principal Display Panel - Bottle Label, 10 Mg – 500 Tablets



NDC 86117-049-12

Acepromazine

Maleate Tablets

10 mg

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Approved by FDA under ANADA # 200-757

Net Contents:

500 Tablets


Principal Display Panel - Bottle Label, 25 Mg – 100 Tablets



NDC 86117-050-07

Acepromazine

Maleate Tablets

25 mg

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Net Contents:

100 Tablets


Principal Display Panel - Bottle Label, 25 Mg – 500 Tablets



NDC 86117-050-12

Acepromazine

Maleate Tablets

25 mg

Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Approved by FDA under ANADA # 200-757

Net Contents:

500 Tablets


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.