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 9 of 17 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirst9a3a142c-daaf-79af-e053-2995a90a1c512025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 1731582
rxcui: 238212
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirst9bde90dd-0300-f705-e053-2a95a90a7ea62025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact 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.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: LKG8494WBH
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackd93a9b2b-708d-4db5-8aae-45fd3a7ca65c2025-01-06Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS IUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOSPHORUS, STAPHYSAGRIA, STRAMONIUMSilver Star Brands05e04129-e7c1-4e11-e063-6394a90a09ca2025-01-01WarningsExact identifier
unii: QTT17582CB
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
unii: LKG8494WBH
CuvposaGLYCOPYRROLATEMerz Pharmaceuticals, LLCd200bd44-9856-4104-a29e-a4cca3db67372024-12-19Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack5ee5f433-fd99-4c8d-8263-b8956d4896202024-12-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
unii: LKG8494WBH
Stress Away Anxiety ReliefACONITUM NAP, ALFALFA, AVENA, CHAMOMILLA, GELSEMIUM, HUMULUS LUPULUS, IGNATIA, KALI ARS, KALI PHOS, MURIATICUM AC, NAT PHOS, PASSIFLORA, PHOS, STAPHYSAG, STRAMONIUMSilver Star Brands9d75666e-3214-2bab-e053-2a95a90af7192024-12-03WarningsExact identifier
unii: QTT17582CB
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
unii: LKG8494WBH
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
unii: LKG8494WBH
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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