FDA.reportPublic FDA data

NDC 0641-6212-01 - Glycopyrrolate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0641-6212
Requested NDC
0641-6212-01
Package NDCs from labels
0641-6212-01, 0641-6212-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2025-10-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate Injection, USPHikma Pharmaceuticals USA Inc.2025-10-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6212-01Glycopyrrolate1 mL in 1 SYRINGE, GLASSINJECTION19
0641-6212-10Glycopyrrolate10 in 1 CARTONINJECTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6212GLYCOPYRROLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, 2 package rows20241208_960d2dd0-008d-4ec1-ba2e-9388b28b23e2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6212-01ML - Milliliter0641-6212fa55f48e-f956-4c70-a47c-afb4dfad4f4b12025-10-14
0641-6212-10ML - Milliliter0641-6212917653b7-4c07-46ad-a04f-595965037bd912025-10-14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 16 of 16 · 310 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYCOPYRROLATEGLYCOPYRROLATEAlembic Labs LLCdb178372-51d2-4194-bbe2-da9acb1cfd532020-12-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATECivica, Inc.9f7f1ebf-58e8-4ae7-8157-1595df8ad6f42020-02-26Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEDr. Reddy's Laboratories Limited725529e8-9c4b-4108-690a-e4f3914397362016-11-15Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.