NDC 15955-305

GLYCOPYRROLATE

Glycopyrrolate

GLYCOPYRROLATE is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Orit Laboratories Llc. The primary component is Glycopyrrolate.

Product ID15955-305_9067d5bb-ad49-4e99-bdd7-6377755000ea
NDC15955-305
Product TypeHuman Prescription Drug
Proprietary NameGLYCOPYRROLATE
Generic NameGlycopyrrolate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2012-10-19
Marketing CategoryANDA / ANDA
Application NumberANDA203657
Labeler NameORIT LABORATORIES LLC
Substance NameGLYCOPYRROLATE
Active Ingredient Strength1 mg/1
Pharm ClassesAnticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 15955-305-01

100 TABLET in 1 BOTTLE, PLASTIC (15955-305-01)
Marketing Start Date2012-10-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 15955-305-01 [15955030501]

GLYCOPYRROLATE TABLET
Marketing CategoryANDA
Application NumberANDA203657
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-10-19

Drug Details

Active Ingredients

IngredientStrength
GLYCOPYRROLATE1 mg/1

Pharmacological Class

  • Anticholinergic [EPC]
  • Cholinergic Antagonists [MoA]
  • Anticholinergic [EPC]
  • Cholinergic Antagonists [MoA]

NDC Crossover Matching brand name "GLYCOPYRROLATE" or generic name "Glycopyrrolate"

NDCBrand NameGeneric Name
0143-1250GlycopyrrolateGlycopyrrolate
0143-1251GlycopyrrolateGlycopyrrolate
0143-9584GlycopyrrolateGlycopyrrolate
0143-9585GlycopyrrolateGlycopyrrolate
0143-9586GlycopyrrolateGlycopyrrolate
0143-9587GlycopyrrolateGlycopyrrolate
0143-9679GlycopyrrolateGlycopyrrolate
0143-9680GlycopyrrolateGlycopyrrolate
0143-9681GlycopyrrolateGlycopyrrolate
0143-9682GlycopyrrolateGlycopyrrolate
0259-0502GlycopyrrolateGlycopyrrolate
0404-9867GLYCOPYRROLATEGLYCOPYRROLATE
0404-9868GLYCOPYRROLATEGLYCOPYRROLATE
0404-9869GLYCOPYRROLATEGLYCOPYRROLATE
0404-9870GLYCOPYRROLATEglycopyrrolate
0517-4601GlycopyrrolateGlycopyrrolate
68001-353GlycopyrrolateGlycopyrrolate
68001-351GlycopyrrolateGlycopyrrolate
68001-352GlycopyrrolateGlycopyrrolate
68001-354GlycopyrrolateGlycopyrrolate
68151-0614GlycopyrrolateGlycopyrrolate
0517-4602GlycopyrrolateGlycopyrrolate
0517-4605GlycopyrrolateGlycopyrrolate
0517-4620GlycopyrrolateGlycopyrrolate
69076-475GLYCOPYRROLATEGLYCOPYRROLATE
69076-476GLYCOPYRROLATEGLYCOPYRROLATE
69067-050GlycopyrrolateGlycopyrrolate
69315-140GlycopyrrolateGlycopyrrolate
69315-139GlycopyrrolateGlycopyrrolate
70069-012GlycopyrrolateGlycopyrrolate
70121-1397GlycopyrrolateGlycopyrrolate
70121-1395GlycopyrrolateGlycopyrrolate
70121-1394GlycopyrrolateGlycopyrrolate
70069-014GlycopyrrolateGlycopyrrolate
70069-011GlycopyrrolateGlycopyrrolate
70069-013GlycopyrrolateGlycopyrrolate
70121-1396GlycopyrrolateGlycopyrrolate
71335-0020GlycopyrrolateGlycopyrrolate
71361-003GlycopyrrolateGlycopyrrolate
71361-002GlycopyrrolateGlycopyrrolate
71361-004GlycopyrrolateGlycopyrrolate
71872-7152GlycopyrrolateGlycopyrrolate
71361-001GlycopyrrolateGlycopyrrolate
71872-7148GlycopyrrolateGlycopyrrolate
71872-7012GlycopyrrolateGlycopyrrolate
71872-7093GlycopyrrolateGlycopyrrolate
71872-7094GlycopyrrolateGlycopyrrolate
76045-203GlycopyrrolateGlycopyrrolate
0615-8170GlycopyrrolateGlycopyrrolate
0641-6034GlycopyrrolateGlycopyrrolate

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.