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 13 of 16 · 307 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEFresenius Kabi USA, LLC54458620-d888-4df6-ae4b-78c3dfed34232023-08-16Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEFresenius Kabi USA, LLC88d3e865-8dca-4c89-b6f7-a34c481f75b92023-08-16Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack4c733750-45fe-4876-8e4f-c61c524704052023-06-06Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC86abf577-562c-5eb1-e053-2a91aa0ac10f2023-06-01Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC66726c2b-27e8-5dd1-e053-2991aa0a1ba72023-06-01Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC69353cc1-f5d4-170b-e053-2a91aa0ad5a52023-05-23Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC6934f467-949f-97cc-e053-2a91aa0a05fb2023-05-23Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC95fbe384-eaff-1f2e-e053-2a95a90a03132023-05-15Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC8f126596-7fbf-7a48-e053-2995a90abac72023-05-15Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC8f12016d-9033-00b4-e053-2a95a90ad02a2023-05-15Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC9c9666bf-841b-03fa-e053-2a95a90abb482023-05-11Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC9e5113b7-1c0c-24bd-e053-2995a90ab94b2023-05-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLCbbf0abe2-8deb-19b2-e053-2a95a90a60a32023-05-08Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLCb622f21f-fa37-1259-e053-2995a90aa7962023-05-04Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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