FDA.reportPublic FDA data

GLYCOPYRROLATE

Product NDC
70069-618
11-digit product format
700690618
Labeler code
70069
Product ID
70069-618_2fc11e36-103a-4967-9130-89ab02d9a1f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYCOPYRROLATE
Dosage form
SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Somerset Therapeutics, LLC
Application
ANDA207639
Marketing category
ANDA
Marketing start
2024-07-31
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
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70069-618-01GLYCOPYRROLATE2 mL in 1 VIALSOLUTION22
70069-618-25GLYCOPYRROLATE25 in 1 CARTONSOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70069-618-01ML - Milliliter70069-61854778c3c-9f7c-4788-97d5-bd0814c878bb12024-09-09
70069-618-25ML - Milliliter70069-61871cf6088-36c4-4b9e-8fc0-8b1bf414a02c12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70069-618GLYCOPYRROLATE SOLUTION [SOMERSET THERAPEUTICS, LLC]2Current NDC, 2 package rows20240901_48cfbd5a-b133-4720-9bd7-65296064ea3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1731582glycopyrrolate 0.2 MG in 1 ML InjectionPSN48cfbd5a-b133-4720-9bd7-65296064ea3c2
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSN48cfbd5a-b133-4720-9bd7-65296064ea3c2
1731590glycopyrrolate 0.4 MG in 2 ML InjectionPSN48cfbd5a-b133-4720-9bd7-65296064ea3c2
17315821 ML glycopyrrolate 0.2 MG/ML InjectionSCD48cfbd5a-b133-4720-9bd7-65296064ea3c2
17315902 ML glycopyrrolate 0.2 MG/ML InjectionSCD48cfbd5a-b133-4720-9bd7-65296064ea3c2
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCD48cfbd5a-b133-4720-9bd7-65296064ea3c2
1731582glycopyrrolate 0.2 MG per 1 ML InjectionSY48cfbd5a-b133-4720-9bd7-65296064ea3c2
1731590glycopyrrolate 0.4 MG per 2 ML InjectionSY48cfbd5a-b133-4720-9bd7-65296064ea3c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70069-618-01700690618012 mL in 1 VIAL2 mlHistorical
70069-618-257006906182525 VIAL in 1 CARTON (70069-618-25) / 2 mL in 1 VIAL (70069-618-01) 25 vial2024-07-31NoNoCurrent