FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
64125-139
11-digit product format
641250139
Labeler code
64125
Product ID
64125-139_a4aaf034-13f3-45f1-ba76-e6e34ab290c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
TABLET
Route
ORAL
Labeler
Excellium Pharmaceutical, Inc.
Application
ANDA090195
Marketing category
ANDA
Marketing start
2012-10-01
Marketing end
0000-00-00
Substance
GLYCOPYRROLATE
Active strength
1 mg/1
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64125-139-012019-11-27C16284748780-19855d018-ea59-cd31-e053-dbdaa90ab51aGlycopyrrolate Tablets Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64125-139-01Glycopyrrolate100 in 1 BOTTLETABLET1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64125-139-01EA - Each64125-1394c4c1bba-ce8a-4688-a234-2e60538cdc3512013-04-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC.]1
GLYCOPYRRONIUMACTIVE MOIETYA14FB57V1DGLYCOPYRROLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC.]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JGLYCOPYRROLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGLYCOPYRROLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYCOPYRROLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLYCOPYRROLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYCOPYRROLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64125-139GLYCOPYRROLATE TABLET [EXCELLIUM PHARMACEUTICAL, INC.]1Legacy NDC, 1 package rows20121003_6899ae9d-5981-4f01-9e55-cd88a79bb209.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197738glycopyrrolate 1 MG Oral TabletPSN6899ae9d-5981-4f01-9e55-cd88a79bb2091
197739glycopyrrolate 2 MG Oral TabletPSN6899ae9d-5981-4f01-9e55-cd88a79bb2091
197738glycopyrrolate 1 MG Oral TabletSCD6899ae9d-5981-4f01-9e55-cd88a79bb2091
197739glycopyrrolate 2 MG Oral TabletSCD6899ae9d-5981-4f01-9e55-cd88a79bb2091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64125-139-0164125013901100 in 1 BOTTLEHistorical