FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
72572-225
11-digit product format
725720225
Labeler code
72572
Product ID
72572-225_4605bea0-172d-4eac-b510-0395189a99ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA090963
Marketing category
ANDA
Marketing start
2019-12-10
Substance
GLYCOPYRROLATE
Active strength
.2 mg/mL
Pharmacologic classes
Anticholinergic [EPC], Cholinergic 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
Rxcui1731582

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
72572-225-01Glycopyrrolate1 mL in 1 VIAL, SINGLE-DOSEINJECTION12
72572-225-25Glycopyrrolate25 in 1 CARTONINJECTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-225-01ML - Milliliter72572-225e0aa5eb7-7ff1-4d70-9e97-a1375024bd5a12019-12-10
72572-225-25ML - Milliliter72572-22578c45fc8-1b8b-45ab-80ac-b87f2f281c0112019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-225GLYCOPYRROLATE INJECTION [CIVICA, INC.]2Current NDC, Legacy NDC, 2 package rows20201024_9f7f1ebf-58e8-4ae7-8157-1595df8ad6f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN9f7f1ebf-58e8-4ae7-8157-1595df8ad6f42
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD9f7f1ebf-58e8-4ae7-8157-1595df8ad6f42
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY9f7f1ebf-58e8-4ae7-8157-1595df8ad6f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-225-01725720225011 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
72572-225-257257202252525 VIAL, SINGLE-DOSE in 1 CARTON (72572-225-25) / 1 mL in 1 VIAL, SINGLE-DOSE (72572-225-01) 2019-12-100000-00-00NoNoCurrent