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NDC 82111-0517-01 DARTISLA ODT 0.85 mg/1 Details

DARTISLA ODT 0.85 mg/1

DARTISLA ODT is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Edenbridge Pharmaceuticals LLC.. The primary component is GLYCOPYRROLATE.

MedlinePlus Drug Summary

Glycopyrrolate is used in combination with other medications to treat ulcers in adults and children 12 years of age and older. Glycopyrrolate (Cuvposa) is used to reduce saliva and drooling in children between 3 and16 years of age that have certain medical conditions that cause drooling. Glycopyrrolate is in a class of medications called anticholinergics. It decreases stomach acid and saliva production by blocking the activity of a certain natural substance in the body.

Related Packages: 82111-0517-01
Last Updated: 06/02/2024
MedLinePlus Full Drug Details: Glycopyrrolate

Product Information

NDC	82111-0517
Product ID	82111-517_326d1b45-cb0b-4dfe-a4ea-27c7b1e73d7f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	DARTISLA ODT
Proprietary Name Suffix	n/a
Non-Proprietary Name	Glycopyrrolate Orally Disintegrating Tablets
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, ORALLY DISINTEGRATING
Route	ORAL
Active Ingredient Strength	0.85
Active Ingredient Units	mg/1
Substance Name	GLYCOPYRROLATE
Labeler Name	Edenbridge Pharmaceuticals LLC.
Pharmaceutical Class	Anticholinergic [EPC], Cholinergic Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA215019
Listing Certified Through	2024-12-31

Package

NDC 82111-0517-01 (82111051701)

Pricing Information	N/A
NDC Package Code	82111-517-01
Billing NDC	82111051701
Package	3 BLISTER PACK in 1 CARTON (82111-517-01) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Marketing Start Date	2023-10-11
NDC Exclude Flag	N