FDA.reportPublic FDA data

NDC 0143-9679-01 - 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
0143-9679
Requested NDC
0143-9679-01
Package NDCs from labels
0143-9679-01, 0143-9679-10
Manufacturer
Henry Schein, Inc.
Effective date
2025-08-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GLYCOPYRROLATE - Henry Schein, Inc.Henry Schein, Inc.2025-08-18HUMAN PRESCRIPTION DRUG LABEL
GLYCOPYRROLATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2025-01-08HUMAN PRESCRIPTION DRUG LABEL
Glycopyrrolate - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-06-01HUMAN PRESCRIPTION DRUG LABEL
GLYCOPYRROLATE - General Injectables and Vaccines, Inc.General Injectables and Vaccines, Inc.2022-12-22HUMAN PRESCRIPTION DRUG LABEL
WATER - Hikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.AHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2022-03-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9679-01Glycopyrrolate20 mL in 1 VIALINJECTION206
0143-9679-10Glycopyrrolate10 in 1 CARTONINJECTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9679GLYCOPYRROLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20220324_516cc4f8-3583-4405-ab66-29d4fcc56d05.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9679-01ML - Milliliter0143-96794b35b7dd-b08e-4a9f-a58e-d86aaaa852f312013-08-02
0143-9679-10ML - Milliliter0143-96794e1a21c2-b85c-41a6-a7a3-c0961c32bf0512013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCOPYRROLATEACTIVE INGREDIENTV92SO9WP2IGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
GLYCOPYRRONIUMACTIVE MOIETYA14FB57V1DGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2
WATERINACTIVE INGREDIENT059QF0KO0RGLYCOPYRROLATE INJECTION [WEST-WARD PHARMACEUTICAL CORP]2

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 16 · 308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
25d0cb7b-02f9-42e1-92d9-ce77ff4916e46d93fc3a-4665-449a-afec-d483339bd2a22025-08-18Warnings, Adverse reactionsExact identifier
spl id: 25d0cb7b-02f9-42e1-92d9-ce77ff4916e4
spl set id: 6d93fc3a-4665-449a-afec-d483339bd2a2
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
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
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
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEAurobindo Pharma Limited4b3f8b3e-6fa8-471b-8bee-3dac5e3ea1b82025-04-17Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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