FDA.reportPublic FDA data

NDC 71288-414-01 - 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
71288-414
Requested NDC
71288-414-01
Package NDCs from labels
71288-414-01, 71288-414-03, 71288-414-02, 71288-414-04, 71288-414-91, 71288-414-92, 71288-414-93, 71288-414-94
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
71288-414-01Glycopyrrolate1 mL in 1 VIAL, SINGLE-DOSEINJECTION16
71288-414-02Glycopyrrolate2 mL in 1 VIAL, SINGLE-DOSEINJECTION26
71288-414-03Glycopyrrolate25 in 1 CARTONINJECTION256
71288-414-04Glycopyrrolate25 in 1 CARTONINJECTION256
71288-414-91Glycopyrrolate1 mL in 1 VIAL, SINGLE-DOSEINJECTION11
71288-414-92Glycopyrrolate25 in 1 CARTONINJECTION251
71288-414-93Glycopyrrolate2 mL in 1 VIAL, SINGLE-DOSEINJECTION21
71288-414-94Glycopyrrolate25 in 1 CARTONINJECTION251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-414GLYCOPYRROLATE INJECTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 4 package rows20231116_02541cfd-b209-49b9-a73f-13ef18dce06d.zip
71288-414GLYCOPYRROLATE 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
71288-414-01ML - Milliliter71288-414f5fff38b-36ce-4663-8728-bbc950b0087612022-07-06
71288-414-02ML - Milliliter71288-414840f5850-63b0-474b-a77c-dce5a133d34812022-08-04
71288-414-03ML - Milliliter71288-41483d53e58-185a-4a78-a2c7-8871249904fb12022-07-06
71288-414-04ML - Milliliter71288-4147eeb2da7-edbf-4246-b5ea-dc49ff7f53aa12022-08-04
71288-414-91ML - Milliliter71288-41493b1cfb8-5cae-4638-ab3d-4e8cd036aac612023-08-08
71288-414-92ML - Milliliter71288-4144ee266fd-f377-4f69-94fe-f952d4b2f15d12023-08-08
71288-414-93ML - Milliliter71288-4149bfdc480-17ad-462a-8df4-e412822271ac12023-08-08
71288-414-94ML - Milliliter71288-41491e85e8e-6dc8-4139-9c81-28fc6cadc97912023-08-08

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 17 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
unii: LKG8494WBH
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEProPharma Distribution430635e8-7c9e-77f6-e063-6294a90a4c8a2025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Zilactin Early Relief Cold SoreBENZYL ALCOHOLASCENT CONSUMER PRODUCTS, INC42ef8bfa-c4d9-01cf-e063-6394a90ac88a2025-11-06WarningsExact identifier
unii: LKG8494WBH
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.83602e34-7a8c-4606-b43e-23ab909b6c1a2025-11-05Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.74d51ba3-0ca0-4a04-aa87-1c243f885bd82025-11-05Warnings, Adverse reactionsExact identifier
rxcui: 238212
unii: V92SO9WP2I
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEAccord Healthcare, Inc.,871797f0-697a-4a29-a37b-d06219e8f2662025-10-17Warnings, Adverse reactionsExact identifier
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHenry Schein, Inc.8b4d1798-c0a7-4661-99cd-1e9a23c163862025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
GlycopyrrolateGLYCOPYRROLATEHikma Pharmaceuticals USA Inc.960d2dd0-008d-4ec1-ba2e-9388b28b23e22025-10-09Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I

Reported adverse events (FAERS/openFDA)#

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