FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
0641-6212
11-digit product format
006416212
Labeler code
0641
Product ID
0641-6212_9cafddcc-42f5-486b-9a17-46d75bd6227b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
NDA017558
Marketing category
NDA
Marketing start
2025-08-28
Substance
GLYCOPYRROLATE
Active strength
.2 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glycopyrrolate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCOPYRROLATE.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV92SO9WP2I
Rxcui2101490, 2101495

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
138c3de2-4b03-4255-92b5-f022482d81bcProduct name420260113
4dc252b1-bb5f-8bb6-4fa8-f3a45efd810eProduct name520250304
f58f10d3-5fa9-4c2e-9a6e-77029e9ed80bProduct name120231002
76dcac30-469f-4f92-9c55-70950d209446Product name120230809
132196a6-5117-4b6e-a9dd-27f2793580c6Product name120230112
ac1f888b-a1db-4d2e-abbc-973f21c2ce1bProduct name120220720
d84dd569-7bf0-1410-25eb-017ef37dd406Product name920210902
7d8c8d5a-f174-4e6b-97b1-6fd615c5df9aProduct name120210204
58b12de9-b891-41c7-9be6-ff47de5ec28bProduct name120180828
9aff7b10-8e47-4b10-9a92-803440a37ce2Product name120180206
ce066c73-ca6f-49fc-83d4-d3cf6728e8a1Product name120160616
fb29b8a9-c2d0-42bb-aea8-9bc2a87db75aProduct name120151113
ab7ba50c-5a47-47e6-8dd6-fa32a52559f6Product name120151109
29ae08d1-069f-9822-4820-152d5dc67797Product name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2101490glycopyrrolate 0.2 MG in 1 ML Prefilled SyringePSN960d2dd0-008d-4ec1-ba2e-9388b28b23e29
2101495glycopyrrolate 0.4 MG in 2 ML Prefilled SyringePSN960d2dd0-008d-4ec1-ba2e-9388b28b23e29
21014901 ML glycopyrrolate 0.2 MG/ML Prefilled SyringeSCD960d2dd0-008d-4ec1-ba2e-9388b28b23e29
21014952 ML glycopyrrolate 0.2 MG/ML Prefilled SyringeSCD960d2dd0-008d-4ec1-ba2e-9388b28b23e29
2101490glycopyrrolate 0.2 MG per 1 ML Prefilled SyringeSY960d2dd0-008d-4ec1-ba2e-9388b28b23e29
2101490glycopyrrolate 0.2 MG/ML per 1 ML Prefilled SyringeSY960d2dd0-008d-4ec1-ba2e-9388b28b23e29
2101495glycopyrrolate 0.2 MG/ML per 2 ML Prefilled SyringeSY960d2dd0-008d-4ec1-ba2e-9388b28b23e29
2101495glycopyrrolate 0.4 MG per 2 ML Prefilled SyringeSY960d2dd0-008d-4ec1-ba2e-9388b28b23e29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0641-6212-01006416212011 mL in 1 SYRINGE, GLASS1 mlHistorical
0641-6212-100064162121010 SYRINGE, GLASS in 1 CARTON (0641-6212-10) / 1 mL in 1 SYRINGE, GLASS (0641-6212-01) 2025-08-28NoNoCurrent