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  4. NDC Product Code: 54868-4216 Acebutolol Hydrochloride

NDC 54868-4216 Acebutolol Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 54868-4216?
  5. Acebutolol Hydrochloride Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing certification is expired.
NDC Product Code:
54868-4216
Proprietary Name:
Acebutolol Hydrochloride
Product Type: [3]
EXPIRED PRODUCT and EXCLUDED from the NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
201b752c-64b4-4687-acc1-3a92bfda864e
Start Marketing Date: [9]
04-22-2005
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
E
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PURPLE (C48327 - LAVENDER OPAQUE)
ORANGE (C48331 - BRIGHT ORANGE OPAQUE)
ORANGE (C48331 - BRING ORANGE OPAQUE)
Shape:
CAPSULE (C48336)
Size(s):
18 MM
23 MM
Imprint(s):
AMNEAL;669
AMNEAL;670
Score:
1

Product Packages

NDC Code 54868-4216-0

Package Description: 30 CAPSULE in 1 BOTTLE

Product Details

What is NDC 54868-4216?

The NDC code 54868-4216 is assigned by the FDA to the product Acebutolol Hydrochloride which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-4216-0 30 capsule in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Acebutolol Hydrochloride?

HYPERTENSION: Acebutolol hydrochloride capsules are indicated for the management of hypertension in adults. It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.VENTRICULAR ARRHYTHMIAS: Acebutolol hydrochloride capsules are indicated in the management of ventricular premature beats; it reduces the total number of premature beats, as well as the number of paired and multiform ventricular ectopic beats, and R-on-T beats.

Which are Acebutolol Hydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Acebutolol Hydrochloride Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Acebutolol Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".