FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
71335-9652
11-digit product format
713359652
Labeler code
71335
Product ID
71335-9652_4315b975-431b-4a6a-8224-04e767e6658d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090195
Marketing category
ANDA
Marketing start
2018-09-22
Substance
GLYCOPYRROLATE
Active strength
1 mg/1
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
GLYCOPYRROLATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV92SO9WP2I
Rxcui197738

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
71335-9652-1Glycopyrrolate30 in 1 BOTTLETABLET30102
71335-9652-2Glycopyrrolate270 in 1 BOTTLETABLET270102
71335-9652-3Glycopyrrolate28 in 1 BOTTLETABLET28102
71335-9652-4Glycopyrrolate90 in 1 BOTTLETABLET90102
71335-9652-5Glycopyrrolate100 in 1 BOTTLETABLET100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9652GLYCOPYRROLATE TABLET [BRYANT RANCH PREPACK]102Current NDC, 5 package rows20241226_5ee5f433-fd99-4c8d-8263-b8956d489620.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197738glycopyrrolate 1 MG Oral TabletPSN5ee5f433-fd99-4c8d-8263-b8956d489620102
197738glycopyrrolate 1 MG Oral TabletSCD5ee5f433-fd99-4c8d-8263-b8956d489620102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9652-17133596520130 TABLET in 1 BOTTLE (71335-9652-1) 30 tablet2024-12-12NoNoHistorical
71335-9652-271335965202270 TABLET in 1 BOTTLE (71335-9652-2) 270 tablet2024-12-12NoNoHistorical
71335-9652-37133596520328 TABLET in 1 BOTTLE (71335-9652-3) 28 tablet2024-12-12NoNoHistorical
71335-9652-47133596520490 TABLET in 1 BOTTLE (71335-9652-4) 90 tablet2024-12-12NoNoHistorical
71335-9652-571335965205100 TABLET in 1 BOTTLE (71335-9652-5) 100 tablet2024-04-01NoNoHistorical