FDA.reportPublic FDA data

NDC 0641-6213-01 - 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
0641-6213
Requested NDC
0641-6213-01
Package NDCs from labels
0641-6213-01, 0641-6213-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2025-10-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Glycopyrrolate Injection, USPHikma Pharmaceuticals USA Inc.2025-10-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6213-01Glycopyrrolate2 mL in 1 SYRINGE, GLASSINJECTION29
0641-6213-10Glycopyrrolate10 in 1 CARTONINJECTION109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6213GLYCOPYRROLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, 2 package rows20241208_960d2dd0-008d-4ec1-ba2e-9388b28b23e2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6213-01ML - Milliliter0641-62135f2c88d7-99ba-47af-a312-df0129a133dc12025-10-14
0641-6213-10ML - Milliliter0641-62137cec7f1f-3c67-4681-b106-08521add963812025-10-14

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 3 of 16 · 310 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GlycopyrrolateGLYCOPYRROLATEGland Pharma Limitedd670bd26-8a44-44be-90e1-107d4c3802332026-04-28Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
glycopyrrolateGLYCOPYRROLATEAmneal Pharmaceuticals LLC741355f5-b695-41bb-a065-4abc687312b22026-04-28Warnings, Adverse reactionsExact identifier
rxcui: 2101495
rxcui: 2101490
unii: V92SO9WP2I
BREZTRIBUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATEAstraZeneca Pharmaceuticals LP715433dc-cb2b-43ea-b6df-c5b4177adc6c2026-04-27Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATESagent Pharmaceuticals55930f87-8964-43b1-b790-c1e6dd2602d22026-04-20Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEBryant Ranch Prepack21c7d201-c0b8-4f16-be4a-681d0b22791e2026-04-03Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Glycopyrrolate Oral SolutionGLYCOPYRROLATE ORAL SOLUTIONSun Pharmaceutical Industries, Inc.e20c9a89-2a81-3c6e-e053-2995a90a98612026-04-02Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATESandoz Inccb1ae370-ec4f-4114-9860-8f736f72b5452026-04-01Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEREMEDYREPACK INC.a338ef22-c243-4075-b02d-bcd5b590104a2026-03-26Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEREMEDYREPACK INC.fafea739-87d0-4421-833f-eb066791504c2026-03-26Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATELifestar Pharma LLC0f4a4b94-71e0-49ed-8f1e-c760e4dd31372026-03-25Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEMajor Pharmaceuticals6e5bfe6d-d321-4f0f-86e2-457d8fd10a6a2026-03-19Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
glycopyrrolateGLYCOPYRROLATEBionpharma Inc.512d3f1e-c35c-87c2-e063-6394a90a8de02026-03-05Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATENCS HealthCare of KY, LLC dba Vangard Labs5ed930b7-a36e-4bf8-b1d1-dad238d3dd182026-02-25Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEBryant Ranch Prepack10ea264f-e157-4e13-9d79-b4228daf359d2026-02-17Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEFlorida Pharmaceutical Products, LLC2cda1ed5-10bb-4651-acbf-be44ad7096652026-02-12Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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