FDA.reportPublic FDA data

Glycopyrrolate

Product NDC
0143-1250
11-digit product format
001431250
Labeler code
0143
Product ID
0143-1250_6ce73874-823f-4018-9a79-98c99897a2ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glycopyrrolate
Dosage form
TABLET
Route
ORAL
Labeler
West-ward Pharmaceutical Corp
Application
ANDA040836
Marketing category
ANDA
Marketing start
2009-03-05
Marketing end
0000-00-00
Substance
GLYCOPYRROLATE
Active strength
1 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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
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
0143-1250-012020-01-31C16284748780-19d75b9d1-0a8c-f424-e053-dadaa90a57ceGlycopyrrolate Tablets, USP Rx Only Revised 02/11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-1250-01Glycopyrrolate100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1250-01EA - Each0143-1250fc6f7b5e-b023-4cc6-a877-fc242c8f0a6f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE TABLET [WEST-WARD PHARMACEUTICAL CORP]4
GLYCOPYRROLATEACTIVE MOIETYV92SO9WP2IGLYCOPYRROLATE TABLET [WEST-WARD PHARMACEUTICAL CORP]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKGLYCOPYRROLATE TABLET [WEST-WARD PHARMACEUTICAL CORP]4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JGLYCOPYRROLATE TABLET [WEST-WARD PHARMACEUTICAL CORP]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGLYCOPYRROLATE TABLET [WEST-WARD PHARMACEUTICAL CORP]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GLYCOPYRROLATE TABLET [WEST-WARD PHARMACEUTICAL CORP]4
POVIDONE K30INACTIVE INGREDIENTU725QWY32XGLYCOPYRROLATE TABLET [WEST-WARD PHARMACEUTICAL CORP]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2GLYCOPYRROLATE TABLET [WEST-WARD PHARMACEUTICAL CORP]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-1250GLYCOPYRROLATE TABLET [WEST-WARD PHARMACEUTICAL CORP]4Legacy NDC, 1 package rows20120411_9690ebaf-be1b-4968-a578-28bd5372f022.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197738glycopyrrolate 1 MG Oral TabletPSN9690ebaf-be1b-4968-a578-28bd5372f0224
197739glycopyrrolate 2 MG Oral TabletPSN9690ebaf-be1b-4968-a578-28bd5372f0224
197738glycopyrrolate 1 MG Oral TabletSCD9690ebaf-be1b-4968-a578-28bd5372f0224
197739glycopyrrolate 2 MG Oral TabletSCD9690ebaf-be1b-4968-a578-28bd5372f0224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
0143-1250-0100143125001100 in 1 BOTTLEHistorical