NDC 43353-906 Diltiazem Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
43353-906
Proprietary Name:
Diltiazem Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aphena Pharma Solutions - Tennessee, Llc
Labeler Code:
43353
Start Marketing Date: [9]
09-25-2009
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PURPLE (C48327 - LAVENDER)
WHITE (C48325)
BLUE (C48333 - BLUE-GREEN)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
18 MM
19 MM
22 MM
Imprint(s):
120
180
240
300
Score:
1

Product Packages

NDC Code 43353-906-79

Package Description: 2160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC

Product Details

What is NDC 43353-906?

The NDC code 43353-906 is assigned by the FDA to the product Diltiazem Hydrochloride which is product labeled by Aphena Pharma Solutions - Tennessee, Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 43353-906-79 2160 capsule, extended release in 1 bottle, plastic . 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 Diltiazem Hydrochloride?

Diltiazem is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with severe hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

Which are Diltiazem Hydrochloride UNII Codes?

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

Which are Diltiazem 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 Diltiazem 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:
  • RxCUI: 830795 - dilTIAZem hydrochloride 360 MG 24HR Extended Release Oral Capsule
  • RxCUI: 830795 - 24 HR diltiazem hydrochloride 360 MG Extended Release Oral Capsule
  • RxCUI: 830795 - diltiazem hydrochloride 360 MG 24 HR Extended Release Oral Capsule
  • RxCUI: 830801 - dilTIAZem hydrochloride 300 MG 24HR Extended Release Oral Capsule
  • RxCUI: 830801 - 24 HR diltiazem hydrochloride 300 MG Extended Release Oral Capsule

* Please review the disclaimer below.

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".