FDA.reportPublic FDA data

NDC 68094-073-01 - 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
68094-073
Requested NDC
68094-073-01
Package NDCs from labels
68094-073-01, 68094-073-58
Manufacturer
Precision Dose, Inc.
Effective date
2025-08-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate - Precision Dose, Inc.Precision Dose, Inc.2025-08-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-073-01Glycopyrrolate5 mL in 1 SYRINGE, PLASTICSOLUTION53
68094-073-58Glycopyrrolate1 in 1 BAGSOLUTION13
68094-073-58Glycopyrrolate50 in 1 CASESOLUTION503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-073-01ML - Milliliter68094-073a9fc7629-d93c-4e68-8b52-97ba118eecab12025-08-11
68094-073-58ML - Milliliter68094-073c84bb0bb-b3e9-42a4-b2b5-01a36d9a1fd212025-08-11

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 5 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirstc4c3be3a-ea28-864f-e053-2a95a90a701a2024-01-30Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirste76bc0e4-68f5-70b4-e053-2a95a90a451e2024-01-22Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack579d2499-6520-41fb-ae52-f3d8b9af89502024-01-12Warnings, Adverse reactionsExact identifier
application number: ANDA204438
rxcui: 999961
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATENorthStar RxLLCed22456b-b488-49ec-b96b-2541f5f3c9552024-01-10Warnings, Adverse reactionsExact identifier
rxcui: 999961
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEFH2 Pharma LLC18ca98ed-522d-470f-bb22-908bbd7d489a2023-12-31Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC0933e843-df2a-3d32-e063-6394a90a10372023-11-02Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATE 1MLGLYCOPYRROLATEXIROMED LLC1bb2fa8a-3318-1e9a-2c79-8371bcae3d1c2023-10-23Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEFresenius Kabi USA, LLC250eeef7-b1a9-45e7-a927-7807232e10be2023-09-22Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: A2I8C7HI9T
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
unii: A2I8C7HI9T
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
unii: A2I8C7HI9T
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: A2I8C7HI9T
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: A2I8C7HI9T
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: A2I8C7HI9T
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

Reported adverse events (FAERS/openFDA)#

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