NDC 0115-5911 Pilocarpine Hydrochloride

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Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
0115-5911
Proprietary Name:
Pilocarpine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Code:
0115
Start Marketing Date: [9]
05-01-2007
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
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Product Details

What is NDC 0115-5911?

The NDC code 0115-5911 is assigned by the FDA to the product Pilocarpine Hydrochloride which is product labeled by Amneal Pharmaceuticals Of New York Llc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 0115-5911-01 100 tablet, film coated in 1 bottle , 0115-5911-03 1000 tablet, film coated 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 Pilocarpine Hydrochloride?

Pilocarpine HCl Tablets are indicated for 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) the treatment of symptoms of dry mouth in patients with Sjogren's syndrome.

What is the NDC to RxNorm Crosswalk for Pilocarpine 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

Pilocarpine


Pilocarpine is used to treat dry mouth caused by radiotherapy in people with head and neck cancer and to treat dry mouth in people with Sjogren's syndrome (a condition that affects the immune system and causes dryness of certain parts of the body such as the eyes and mouth). Pilocarpine is in a class of medications called cholinergic agonists. It works by increasing the amount of saliva in the mouth.
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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".