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 3 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.74d51ba3-0ca0-4a04-aa87-1c243f885bd82025-11-05Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEAccord Healthcare, Inc.,871797f0-697a-4a29-a37b-d06219e8f2662025-10-17Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.8b4d1798-c0a7-4661-99cd-1e9a23c163862025-10-16Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHikma Pharmaceuticals USA Inc.960d2dd0-008d-4ec1-ba2e-9388b28b23e22025-10-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution3f2b4281-55f3-43e3-e063-6294a90a56ba2025-09-18Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEProPharma Distribution3edcc39d-0e29-4585-e063-6394a90ad5122025-09-15Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution3edd6a26-dd0f-2411-e063-6394a90affa22025-09-15Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEAlembic Pharmaceuticals Inc.327f8a9e-7730-4f38-a7aa-fbddebddf1732025-08-26Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEPrecision Dose, Inc.e58f860b-e955-4d71-a128-93bd3812b08d2025-08-08Warnings, Adverse reactionsExact identifier
application number: ANDA204438
ndc (package): 68094-073-58
ndc (package): 68094-073-01
ndc (product): 68094-073
ndc11 (package): 68094007301
rxcui: 999961
spl id: 0a84301a-febc-4552-97d6-1fd16f191545
spl set id: e58f860b-e955-4d71-a128-93bd3812b08d
unii: V92SO9WP2I
GLYRX-PFGLYCOPYRROLATEExela Pharma Sciences, LLC2189f3f5-39dc-4e85-b7c6-9515ded596862025-07-23Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEQUAGEN PHARMACEUTICALS LLCa456eaea-4cd6-4344-8fc6-6f6a3ce0f2c62025-06-14Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: A2I8C7HI9T
GLYCOPYRROLATEGLYCOPYRROLATEAmerican Health Packaging6404fc8e-d109-4950-9dca-c8a85ad90cf32025-05-18Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATELeading Pharma, LLC498bce66-6072-4212-8413-ff9888c58f9c2025-04-25Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEChartwell RX, LLC89090b34-470c-478c-be49-1d2bc48a28f82025-04-17Warnings, Adverse reactionsExact identifier
rxcui: 999961
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEAurobindo Pharma Limited4b3f8b3e-6fa8-471b-8bee-3dac5e3ea1b82025-04-17Warnings, Adverse reactionsExact identifier
rxcui: 999961
unii: V92SO9WP2I
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: A2I8C7HI9T
GlycopyrrolateGLYCOPYRROLATEAvPAKbd497783-e2d1-130c-e053-2995a90a7fb92025-03-04Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATECaplin Steriles Limited765490fa-8378-40c8-9fa7-b0bfa2e1a0a92025-01-25Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirst9a3a142c-daaf-79af-e053-2995a90a1c512025-01-08Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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