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 13 of 16 · 308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 059QF0KO0R
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEFresenius Kabi USA, LLC54458620-d888-4df6-ae4b-78c3dfed34232023-08-16Warnings, Adverse reactionsExact identifier
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEFresenius Kabi USA, LLC88d3e865-8dca-4c89-b6f7-a34c481f75b92023-08-16Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack4c733750-45fe-4876-8e4f-c61c524704052023-06-06Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC86abf577-562c-5eb1-e053-2a91aa0ac10f2023-06-01Warnings, Adverse reactionsExact identifier
application number: ANDA090963
ndc (package): 71872-7013-1
ndc (product): 71872-7013
rxcui: 238212
spl id: fd1a483b-00df-5124-e053-6394a90a2f3b
spl set id: 86abf577-562c-5eb1-e053-2a91aa0ac10f
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC66726c2b-27e8-5dd1-e053-2991aa0a1ba72023-06-01Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC69353cc1-f5d4-170b-e053-2a91aa0ad5a52023-05-23Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC6934f467-949f-97cc-e053-2a91aa0a05fb2023-05-23Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC95fbe384-eaff-1f2e-e053-2a95a90a03132023-05-15Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC8f126596-7fbf-7a48-e053-2995a90abac72023-05-15Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC8f12016d-9033-00b4-e053-2a95a90ad02a2023-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC9c9666bf-841b-03fa-e053-2a95a90abb482023-05-11Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLC9e5113b7-1c0c-24bd-e053-2995a90ab94b2023-05-09Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLCbbf0abe2-8deb-19b2-e053-2a95a90a60a32023-05-08Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMedical Purchasing Solutions, LLCb622f21f-fa37-1259-e053-2995a90aa7962023-05-04Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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