FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
0781-3825
11-digit product format
007813825
Labeler code
0781
Product ID
0781-3825_61974545-5e98-4c25-8ce4-6b9c7fd28d40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sandoz Inc
Application
ANDA211334
Marketing category
ANDA
Marketing start
2019-07-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Glycopyrrolate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCOPYRROLATE.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV92SO9WP2I
Rxcui238212, 1731582, 1731590

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
0781-3825-71Glycopyrrolate1 mL in 1 VIALINJECTION111
0781-3825-96Glycopyrrolate25 in 1 CARTONINJECTION2511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3825GLYCOPYRROLATE INJECTION [SANDOZ INC]8Current NDC, Legacy NDC, 2 package rows20221015_cb1ae370-ec4f-4114-9860-8f736f72b545.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSNcb1ae370-ec4f-4114-9860-8f736f72b54511
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSNcb1ae370-ec4f-4114-9860-8f736f72b54511
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSNcb1ae370-ec4f-4114-9860-8f736f72b54511
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCDcb1ae370-ec4f-4114-9860-8f736f72b54511
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCDcb1ae370-ec4f-4114-9860-8f736f72b54511
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCDcb1ae370-ec4f-4114-9860-8f736f72b54511
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSYcb1ae370-ec4f-4114-9860-8f736f72b54511
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSYcb1ae370-ec4f-4114-9860-8f736f72b54511
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN9c9666bf-841b-03fa-e053-2a95a90abb482
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD9c9666bf-841b-03fa-e053-2a95a90abb482
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY9c9666bf-841b-03fa-e053-2a95a90abb482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-3825-71007813825711 mL in 1 VIAL1 mlHistorical
0781-3825-960078138259625 VIAL in 1 CARTON (0781-3825-96) / 1 mL in 1 VIAL (0781-3825-71) 25 vial2019-07-220000-00-00NoNoCurrent