FDA.reportPublic FDA data

NDC 70518-4597-01 - 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
70518-4597
Requested NDC
70518-4597-01
Package NDCs from labels
70518-4597-1, 70518-4597-0, 70518-4597-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-03-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate - REMEDYREPACK INC.REMEDYREPACK INC.2026-03-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4597-0Glycopyrrolate100 in 1 BOXTABLET1001
70518-4597-1Glycopyrrolate1 in 1 POUCHTABLET11

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 6 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATELeading Pharma, LLC498bce66-6072-4212-8413-ff9888c58f9c2025-04-25Warnings, Adverse reactionsExact identifier
rxcui: 197739
rxcui: 197738
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEChartwell RX, LLC89090b34-470c-478c-be49-1d2bc48a28f82025-04-17Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEAurobindo Pharma Limited4b3f8b3e-6fa8-471b-8bee-3dac5e3ea1b82025-04-17Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEAvPAKbd497783-e2d1-130c-e053-2995a90a7fb92025-03-04Warnings, Adverse reactionsExact identifier
rxcui: 197738
unii: V92SO9WP2I
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
Dairy-Grain-NightshadesIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba83c60-35be-181a-e053-2a95a90a98952025-02-06WarningsExact identifier
unii: J2B2A4N98G
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
GLYCOPYRROLATEGLYCOPYRROLATEHF Acquisition Co LLC, DBA HealthFirst9bde90dd-0300-f705-e053-2a95a90a7ea62025-01-08Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackd93a9b2b-708d-4db5-8aae-45fd3a7ca65c2025-01-06Warnings, Adverse reactionsExact identifier
rxcui: 197738
unii: V92SO9WP2I
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
rxcui: 197738
unii: V92SO9WP2I
glycopyrrolateGLYCOPYRROLATESaptalis Pharmaceuticals, LLC.3e6f8091-d6fe-4c8f-b897-606a70bf74bc2024-11-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
GlycopyrrolateGLYCOPYRROLATEFresenius Kabi USA, LLCccafb5c2-86dd-4bb2-883a-c13e3171227c2024-10-14Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack987ba524-361e-49c3-9e00-550a787485422024-10-09Warnings, Adverse reactionsExact identifier
rxcui: 197739
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack48a8356e-377e-45ef-a1bf-e9ffec0517492024-10-08Warnings, Adverse reactionsExact identifier
rxcui: 197738
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepackfcb295e4-038f-4d4f-8786-4fbcd1d3c2982024-10-04Warnings, Adverse reactionsExact identifier
rxcui: 197739
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack33bbc475-2fe3-48ab-8a9d-56d13053593e2024-10-04Warnings, Adverse reactionsExact identifier
rxcui: 197739
unii: V92SO9WP2I
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, FORMALINUM, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), LAC DEFLORATUM, LAC VACCINUM, MENADIONE, OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PHENYL ISOTHIOCYANATE, QUERCETIN, RUTIN, SACCHARUM LACTIS, ILEUM (SUIS), JEJUNUM (SUIS), STOMACH (SUIS), COUMARINUM, FOLLICULINUM, GABA (GAMMA-AMINOBUTYRIC ACID), SARCOLACTICUM ACIDUM, LAC CANINUM, LAC FELINUM, LAC HUMANUM, PIPERINE, CALCAREA CARBONICA,Deseret Biologicals, Inc.e03d8463-287a-4509-a9f4-0ad38a98377c2024-09-11WarningsExact identifier
unii: J2B2A4N98G

Reported adverse events (FAERS/openFDA)#

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