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GLYCOPYRROLATE 1ML

Glycopyrrolate Injection

Approved
Approval ID

1bb2fa8a-3318-1e9a-2c79-8371bcae3d1c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 23, 2023

Manufacturers
FDA

XIROMED LLC

DUNS: 080228637

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Glycopyrrolate

PRODUCT DETAILS

NDC Product Code70700-264
Application NumberANDA212227
Marketing CategoryC73584
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateMarch 19, 2019
Generic NameGlycopyrrolate

INGREDIENTS (5)

GLYCOPYRROLATEActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
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GLYCOPYRROLATE 1ML - FDA Approval | MedPath