NDC 52959-168 Dicyclomine 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:
52959-168
Proprietary Name:
Dicyclomine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
H.j. Harkins Company Inc.
Labeler Code:
52959
Start Marketing Date: [9]
01-03-2017
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
TURQUOISE (C48334)
Shape:
CAPSULE (C48336)
Size(s):
14 MM
Imprint(s):
MYLAN;1610

Product Packages

NDC Code 52959-168-00

Package Description: 100 CAPSULE in 1 CONTAINER

NDC Code 52959-168-12

Package Description: 12 CAPSULE in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

NDC Code 52959-168-30

Package Description: 30 CAPSULE in 1 CONTAINER

NDC Code 52959-168-40

Package Description: 40 CAPSULE in 1 CONTAINER

Product Details

What is NDC 52959-168?

The NDC code 52959-168 is assigned by the FDA to the product Dicyclomine Hydrochloride which is product labeled by H.j. Harkins Company Inc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 52959-168-00 100 capsule in 1 container , 52959-168-12 12 capsule in 1 container, flexible intermediate bulk , 52959-168-30 30 capsule in 1 container , 52959-168-40 40 capsule in 1 container . 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 Dicyclomine Hydrochloride?

Dicyclomine hydrochloride is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

Which are Dicyclomine Hydrochloride UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Dicyclomine 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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Patient Education

Dicyclomine


Dicyclomine is used to treat the symptoms of irritable bowel syndrome. Dicyclomine is in a class of medications called anticholinergics. It relieves muscle spasms in the gastrointestinal tract by blocking the activity of a certain natural substance in the body.
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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".