FDA.reportPublic FDA data

NDC 0143-9587-01 - 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
0143-9587
Requested NDC
0143-9587-01
Package NDCs from labels
0143-9587-01, 0143-9587-25
Manufacturer
Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2022-03-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
WATER - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2022-03-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9587-01Glycopyrrolate1 mL in 1 VIAL, SINGLE-DOSEINJECTION110
0143-9587-25Glycopyrrolate25 in 1 CARTONINJECTION2510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9587GLYCOPYRROLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20220311_d5a18d74-0d40-46e2-aa0a-41d18609a536.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9587-01ML - Milliliter0143-95873ca57585-9579-44e2-b7a5-030aad0390c112015-08-04
0143-9587-25ML - Milliliter0143-9587bd40b1e1-c2bd-486b-9c87-a07915d5718312015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
GLYCOPYRRONIUMACTIVE MOIETYA14FB57V1DGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
WATERINACTIVE INGREDIENT059QF0KO0RGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2

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 16 of 17 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATECamber Pharmaceuticals, Inc.4741be85-3abb-4545-aba9-281f64d210ec2022-07-13Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
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
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEXiromed, LLCf777c813-3232-d744-8bcf-58e86fb929bd2022-04-12Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHikma Pharmaceuticals USA Inc.516cc4f8-3583-4405-ab66-29d4fcc56d052022-03-23Warnings, Adverse reactionsExact identifier
application number: ANDA090963
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHikma Pharmaceuticals USA Inc.d5a18d74-0d40-46e2-aa0a-41d18609a5362022-03-04Warnings, Adverse reactionsExact identifier
application number: ANDA090963
ndc (package): 0143-9585-25
ndc (package): 0143-9587-25
ndc (package): 0143-9586-01
ndc (package): 0143-9584-10
ndc (package): 0143-9586-25
ndc (package): 0143-9584-01
ndc (package): 0143-9585-01
ndc (package): 0143-9587-01
ndc (product): 0143-9584
ndc (product): 0143-9585
ndc (product): 0143-9587
ndc (product): 0143-9586
ndc11 (package): 00143958701
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
spl id: d0ab666e-f450-4de6-a324-9c45be693df0
spl set id: d5a18d74-0d40-46e2-aa0a-41d18609a536
unii: V92SO9WP2I
glycopyrrolateGLYCOPYRROLATEBE Pharmaceuticals Inc.d9df3900-a8c2-438b-8971-ba11ff91f90b2022-02-24Warnings, Adverse reactionsExact identifier
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
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
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
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
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATENivagen Pharmaceuticals, Inc.7cb1ecbe-1e7a-4b39-8e1d-0c20f145e1772021-10-29Warnings, Adverse reactionsExact identifier
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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