FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
49884-065
11-digit product format
498840065
Labeler code
49884
Product ID
49884-065_1b923cd6-6a35-4f2f-bcb8-cab438977a08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
glycopyrrolate
Dosage form
TABLET
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA040653
Marketing category
ANDA
Marketing start
2006-09-26
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, 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
49884-065-01Glycopyrrolate100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-065-01EA - Each49884-065a626ccd5-11c6-4530-bf33-b9e8bafbd71512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
GLYCOPYRROLATEACTIVE MOIETYV92SO9WP2IGLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPGLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GGLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EGLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYCOPYRROLATE TABLET [PAR PHARMACEUTICAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-065GLYCOPYRROLATE TABLET [ENDO USA, INC.]6Current NDC, Legacy NDC, 1 package rows20240926_1f266d77-4f9e-44c9-a000-2f8fea3ac80b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197738glycopyrrolate 1 MG Oral TabletPSNf7187ddb-ea11-4aa8-8215-a5fcf0f1ca7c106
197738glycopyrrolate 1 MG Oral TabletSCDf7187ddb-ea11-4aa8-8215-a5fcf0f1ca7c106
197738glycopyrrolate 1 MG Oral TabletPSN48a8356e-377e-45ef-a1bf-e9ffec051749103
197738glycopyrrolate 1 MG Oral TabletSCD48a8356e-377e-45ef-a1bf-e9ffec051749103
197738glycopyrrolate 1 MG Oral TabletPSNd93a9b2b-708d-4db5-8aae-45fd3a7ca65c102
197738glycopyrrolate 1 MG Oral TabletSCDd93a9b2b-708d-4db5-8aae-45fd3a7ca65c102
197738glycopyrrolate 1 MG Oral TabletPSN1f266d77-4f9e-44c9-a000-2f8fea3ac80b6
197739glycopyrrolate 2 MG Oral TabletPSN1f266d77-4f9e-44c9-a000-2f8fea3ac80b6
197738glycopyrrolate 1 MG Oral TabletSCD1f266d77-4f9e-44c9-a000-2f8fea3ac80b6
197739glycopyrrolate 2 MG Oral TabletSCD1f266d77-4f9e-44c9-a000-2f8fea3ac80b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-065-0149884006501100 TABLET in 1 BOTTLE (49884-065-01) 100 tablet2006-09-260000-00-00NoNoCurrent