FDA.reportPublic FDA data

NDC 0641-6107-01 - Robinul

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
0641-6107
Requested NDC
0641-6107-01
Package NDCs from labels
0641-6107-01, 0641-6107-10
Manufacturer
West-Ward Pharmaceuticals Corp.
Effective date
2017-06-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ROBINUL Injection (glycopyrrolate injection, USP)West-Ward Pharmaceuticals Corp.2017-06-29HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6107ROBINUL INJECTION [WEST-WARD PHARMACEUTICALS CORP.]3Legacy NDC20171202_38f88829-a226-4810-866c-1b62c47e8aee.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6107-01ML - Milliliter0641-61076584d60f-3f6b-4de2-ab99-7de9a62a300212013-02-13
0641-6107-10ML - Milliliter0641-610702dd02e4-aaa5-4a37-bb2a-d25d676ef84e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IROBINUL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
GLYCOPYRROLATEACTIVE MOIETYV92SO9WP2IROBINUL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHROBINUL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBROBINUL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IROBINUL INJECTION [WEST-WARD PHARMACEUTICAL CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RROBINUL 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 10 of 17 · 338 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
glycopyrrolateGLYCOPYRROLATESaptalis Pharmaceuticals, LLC.3e6f8091-d6fe-4c8f-b897-606a70bf74bc2024-11-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: LKG8494WBH
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEFresenius Kabi USA, LLCccafb5c2-86dd-4bb2-883a-c13e3171227c2024-10-14Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack987ba524-361e-49c3-9e00-550a787485422024-10-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack48a8356e-377e-45ef-a1bf-e9ffec0517492024-10-08Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
unii: LKG8494WBH
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackfcb295e4-038f-4d4f-8786-4fbcd1d3c2982024-10-04Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack33bbc475-2fe3-48ab-8a9d-56d13053593e2024-10-04Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
CVS Health Lidocaine Plus Pain RelievingLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNATURAL ESSENTIALS, INC.1adb9b74-4a01-4461-b845-f3aedcb3f8102024-10-01WarningsExact identifier
unii: LKG8494WBH
GLYCOPYRROLATEGLYCOPYRROLATESomerset Therapeutics, LLC48cfbd5a-b133-4720-9bd7-65296064ea3c2024-08-31Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
EmpathyAETHUSA CYNAPIUM, AMBRA GRISEA, ARGEMONE MEXICANA, CANDIDA ALBICANS, CARLSBAD AQUA, CEREBRUM SUIS, COCCULUS INDICUS, COFFEA TOSTA, CROCUS SATIVUS, CYCLAMEN EUROPAEUM, MAGNESIA CARBONICA, NATRUM CARBONICUM, NUPHAR LUTEUM, NUX MOSCHATA, PHOSPHORUS, PLACENTA TOTALIS SUIS, ROSA DAMASCENA, SUCCINUM, VIOLA ODORATADeseret Biologicals, Inc.a89067c1-ef12-49da-8fa6-e65ff664f4972024-08-13WarningsExact identifier
unii: 059QF0KO0R
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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