FDA.reportPublic FDA data

GLYCOPYRROLATE

Product NDC
70752-109
11-digit product format
707520109
Labeler code
70752
Product ID
70752-109_b1a27fc3-9dba-4a06-9033-349cace6a181
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GLYCOPYRROLATE
Dosage form
TABLET
Route
ORAL
Labeler
QUAGEN PHARMACEUTICALS LLC
Application
ANDA212696
Marketing category
ANDA
Marketing start
2024-10-10
Substance
GLYCOPYRROLATE
Active strength
2 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
GLYCOPYRROLATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV92SO9WP2I
Rxcui197738, 197739

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
70752-109-10GLYCOPYRROLATE100 in 1 BOTTLE, PLASTICTablet1004
70752-109-11GLYCOPYRROLATE1000 in 1 BOTTLE, PLASTICTablet10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70752-109-10EA - Each70752-1094219a3dc-5f1f-4b6d-9d8d-c43155402ffa12025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70752-109GLYCOPYRROLATE TABLET [QUAGEN PHARMACEUTICALS LLC]3Current NDC, 2 package rows20241021_a456eaea-4cd6-4344-8fc6-6f6a3ce0f2c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197739glycopyrrolate 2 MG Oral TabletPSNb96c54a1-b8a5-4132-ae6d-725e0e5b91f4100
197739glycopyrrolate 2 MG Oral TabletSCDb96c54a1-b8a5-4132-ae6d-725e0e5b91f4100
197738glycopyrrolate 1 MG Oral TabletPSNa456eaea-4cd6-4344-8fc6-6f6a3ce0f2c64
197739glycopyrrolate 2 MG Oral TabletPSNa456eaea-4cd6-4344-8fc6-6f6a3ce0f2c64
197738glycopyrrolate 1 MG Oral TabletSCDa456eaea-4cd6-4344-8fc6-6f6a3ce0f2c64
197739glycopyrrolate 2 MG Oral TabletSCDa456eaea-4cd6-4344-8fc6-6f6a3ce0f2c64
197739glycopyrrolate 2 MG Oral TabletPSN5d7a742e-2bcf-4db4-a07c-f669938e40681
197739glycopyrrolate 2 MG Oral TabletSCD5d7a742e-2bcf-4db4-a07c-f669938e40681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70752-109-1070752010910100 TABLET in 1 BOTTLE, PLASTIC (70752-109-10) 100 tablet2024-10-10NoNoCurrent
70752-109-11707520109111000 TABLET in 1 BOTTLE, PLASTIC (70752-109-11) 1000 tablet2024-10-10NoNoCurrent