FDA.reportPublic FDA data

NDC 71288-415-97 - 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
71288-415
Requested NDC
71288-415-97
Package NDCs from labels
71288-415-05, 71288-415-06, 71288-415-20, 71288-415-21, 71288-415-95, 71288-415-96, 71288-415-97, 71288-415-98
Manufacturer
Meitheal Pharmaceuticals Inc. | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
Effective date
2026-05-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GlycopyrrolateMeitheal Pharmaceuticals Inc. | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.2026-05-20HUMAN PRESCRIPTION DRUG LABEL
Glycopyrrolate Injection, USP (For Intramuscular or Intravenous Use)Meitheal Pharmaceuticals Inc.2023-01-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-415-05Glycopyrrolate5 mL in 1 VIAL, MULTI-DOSEINJECTION56
71288-415-06Glycopyrrolate25 in 1 CARTONINJECTION256
71288-415-20Glycopyrrolate20 mL in 1 VIAL, MULTI-DOSEINJECTION206
71288-415-21Glycopyrrolate10 in 1 CARTONINJECTION106
71288-415-95Glycopyrrolate5 mL in 1 VIAL, MULTI-DOSEINJECTION51
71288-415-96Glycopyrrolate25 in 1 CARTONINJECTION251
71288-415-97Glycopyrrolate20 mL in 1 VIAL, MULTI-DOSEINJECTION201
71288-415-98Glycopyrrolate10 in 1 CARTONINJECTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-415GLYCOPYRROLATE INJECTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20231116_02541cfd-b209-49b9-a73f-13ef18dce06d.zip
71288-415GLYCOPYRROLATE INJECTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 4 package rows20230119_02f914a8-2356-4525-91ff-cf0c9e41ba23.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-415-05ML - Milliliter71288-415e28daf9c-36b4-48fc-a82d-bf37677148a012022-08-04
71288-415-06ML - Milliliter71288-415c208b466-fe57-4cc8-93f2-d3d871c0823112022-08-04
71288-415-20ML - Milliliter71288-4153194b506-003e-42d2-a906-8baf97c5397f12022-05-04
71288-415-21ML - Milliliter71288-4158edc4df4-995d-47d0-91e2-be09616cf2b212022-05-04

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 7 of 17 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution3f2b4281-55f3-43e3-e063-6294a90a56ba2025-09-18Warnings, Adverse reactionsExact identifier
rxcui: 1731590
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEProPharma Distribution3edcc39d-0e29-4585-e063-6394a90ad5122025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution3edd6a26-dd0f-2411-e063-6394a90affa22025-09-15Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEAlembic Pharmaceuticals Inc.327f8a9e-7730-4f38-a7aa-fbddebddf1732025-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEPrecision Dose, Inc.e58f860b-e955-4d71-a128-93bd3812b08d2025-08-08Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYRX-PFGLYCOPYRROLATEExela Pharma Sciences, LLC2189f3f5-39dc-4e85-b7c6-9515ded596862025-07-23Warnings, Adverse reactionsExact identifier
rxcui: 1731582
rxcui: 1731590
unii: V92SO9WP2I
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
GLYCOPYRROLATEGLYCOPYRROLATEQUAGEN PHARMACEUTICALS LLCa456eaea-4cd6-4344-8fc6-6f6a3ce0f2c62025-06-14Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GLYCOPYRROLATEGLYCOPYRROLATEAmerican Health Packaging6404fc8e-d109-4950-9dca-c8a85ad90cf32025-05-18Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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