NDC 0641-6212-01 - 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
0641-6212
Requested NDC
0641-6212-01
Package NDCs from labels
0641-6212-01, 0641-6212-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2025-10-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate Injection, USPHikma Pharmaceuticals USA Inc.2025-10-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6212-01Glycopyrrolate1 mL in 1 SYRINGE, GLASSINJECTION19
0641-6212-10Glycopyrrolate10 in 1 CARTONINJECTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6212GLYCOPYRROLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, 2 package rows20241208_960d2dd0-008d-4ec1-ba2e-9388b28b23e2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6212-01ML - Milliliter0641-6212fa55f48e-f956-4c70-a47c-afb4dfad4f4b12025-10-14
0641-6212-10ML - Milliliter0641-6212917653b7-4c07-46ad-a04f-595965037bd912025-10-14

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 15 of 16 · 310 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GLYCOPYRROLATEGLYCOPYRROLATENovadoz Pharmaceuticals LLC98820c01-1853-45d8-9da5-875fcdf5f9ab2022-06-14Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEXiromed LLC29618edf-39b0-022a-9875-9d865450d3182022-04-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEXiromed, LLCf777c813-3232-d744-8bcf-58e86fb929bd2022-04-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHikma Pharmaceuticals USA Inc.516cc4f8-3583-4405-ab66-29d4fcc56d052022-03-23Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHikma Pharmaceuticals USA Inc.d5a18d74-0d40-46e2-aa0a-41d18609a5362022-03-04Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
glycopyrrolateGLYCOPYRROLATEBE Pharmaceuticals Inc.d9df3900-a8c2-438b-8971-ba11ff91f90b2022-02-24Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATESomerset Therapeutics, LLCa46c5ec1-a1b4-46fc-9b37-8da7f0c983d62022-01-27Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
BHI HemorrhoidHORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFURMediNatura Incd7df7d3e-48ad-4f58-aef5-a7bd48d2f1912022-01-05WarningsExact identifier
unii: QTT17582CB
Joette Calabrese Survivalist KitABROT ACON AGN AIL AMBR AMBRO AM-C ANT-C APIS ARN ARS AUR-A AUR BAPT BAR-C BELL BB BOTH BOV BROM CADM-S CALAD CALC CAMPH CARB-AC CARD-M CEAN CHEL CHININ-A CINA CHIN CIC COB COLCH CON CROT-H CROT-T CUPR DULC ELAPS EUP-PER FL-AC GALPH GRAPH GUNP HAM HEKLA HELL HEP HYDR-AC HYOS HYPER KALI-BR KALI-C KALI-I LATH LAUR LED LOB MERC-CY MERC MEZ MOSCH MUR-AC NAJA NAT-C NIT-AC NUX-M PYROG PH-AC PIC-AC PLB RHUS-T RUTA SAMB SANG SARR SEP STRAM SUL-AC TAB TERENT TER TEUCR VERAT VERAT-V VIPOHM PHARMA INC.1ac2a2c4-704e-4efa-aa44-acc71d300f702021-12-29WarningsExact identifier
unii: QTT17582CB
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEAuroMedics Pharma LLCeaebb511-1738-4d11-b9bb-317a8d41316a2021-12-22Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATENivagen Pharmaceuticals, Inc.7cb1ecbe-1e7a-4b39-8e1d-0c20f145e1772021-10-29Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FungisodeARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHURSeroyal USA55c5dfc4-3757-6ac2-e054-00144ff88e882021-07-22WarningsExact identifier
unii: QTT17582CB
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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