Glycopyrrolate

Product NDC
70700-902
11-digit product format
707000902
Labeler code
70700
Product ID
70700-902_c69bb9fb-1204-4258-bdf0-4c83cb2067b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Xiromed, LLC
Application
ANDA212612
Marketing category
ANDA
Marketing start
2021-11-09
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

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
70700-902-22Glycopyrrolate5 mL in 1 VIALINJECTION53
70700-902-25Glycopyrrolate25 in 1 CARTONINJECTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70700-902-22ML - Milliliter70700-902cf229631-a5ac-4713-b7e8-838f72781e0012021-12-08
70700-902-25ML - Milliliter70700-902a5f62ccb-94b6-44a6-ba2d-49a820aa6ddd12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-902GLYCOPYRROLATE INJECTION [XIROMED, LLC ]3Current NDC, Legacy NDC, 2 package rows20250112_f777c813-3232-d744-8bcf-58e86fb929bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238212glycopyrrolate 0.2 MG/ML Injectable SolutionPSNf777c813-3232-d744-8bcf-58e86fb929bd3
238212glycopyrrolate 0.2 MG/ML Injectable SolutionSCDf777c813-3232-d744-8bcf-58e86fb929bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70700-902-22707000902225 mL in 1 VIAL5 mlHistorical
70700-902-257070009022525 VIAL in 1 CARTON (70700-902-25) / 5 mL in 1 VIAL (70700-902-22) 25 vial2021-11-090000-00-00NoNoCurrent