FDA.reportPublic FDA data

NDC 0641-6035-01 - Glycopyrrolate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0641-6035
Requested NDC
0641-6035-01
Package NDCs from labels
0641-6035-01, 0641-6035-25
Manufacturer
West-ward Pharmaceutical Corp.
Effective date
2012-02-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate Injection, USPWest-ward Pharmaceutical Corp.2012-02-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-6035-252019-11-13C16284748780-197449f38-ba6e-f6ea-e053-dbdaa90aa703Glycopyrrolate Injection, USP

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6035GLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3Legacy NDC20120612_61767a0d-c94c-44d8-b35c-316a5731a275.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6035-01ML - Milliliter0641-60356ee1ffa7-8837-44b9-bf41-6de0e79f42f712013-02-13
0641-6035-25ML - Milliliter0641-6035b45f5ffb-a1b6-44c6-99ff-5cdd3c36bf0212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
GLYCOPYRROLATEACTIVE MOIETYV92SO9WP2IGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3
WATERINACTIVE INGREDIENT059QF0KO0RGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]3

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution430635e8-7c9e-77f6-e063-6294a90a4c8a2025-11-07Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.83602e34-7a8c-4606-b43e-23ab909b6c1a2025-11-05Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.74d51ba3-0ca0-4a04-aa87-1c243f885bd82025-11-05Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEAccord Healthcare, Inc.,871797f0-697a-4a29-a37b-d06219e8f2662025-10-17Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.8b4d1798-c0a7-4661-99cd-1e9a23c163862025-10-16Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHikma Pharmaceuticals USA Inc.960d2dd0-008d-4ec1-ba2e-9388b28b23e22025-10-09Warnings, Adverse reactionsExact identifier
application number: NDA017558
unii: V92SO9WP2I
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution3f2b4281-55f3-43e3-e063-6294a90a56ba2025-09-18Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEProPharma Distribution3edcc39d-0e29-4585-e063-6394a90ad5122025-09-15Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution3edd6a26-dd0f-2411-e063-6394a90affa22025-09-15Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.