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 2 of 17 · 337 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: LKG8494WBH
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEPiramal Critical Care Inc83d70378-011b-4ce3-e053-2991aa0a22be2026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
unii: V92SO9WP2I
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATECardinal Health 107, LLC65688bed-0d70-4b51-8301-1948b1deade12026-06-02Warnings, Adverse reactionsExact identifier
rxcui: 1731582
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEREMEDYREPACK INC.220cd5f5-3d71-4fdb-9943-7468799c179f2026-06-02Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
GLYCOPYRROLATEGLYCOPYRROLATEGolden State Medical Supply, Inc.ec15e70c-8473-469a-9f07-ea668783fa072026-05-27Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycopyrrolateGLYCOPYRROLATEMeitheal Pharmaceuticals Inc.02541cfd-b209-49b9-a73f-13ef18dce06d2026-05-20Warnings, Adverse reactionsExact identifier
application number: ANDA212802
ndc (package): 71288-414-02
ndc (package): 71288-415-06
ndc (package): 71288-415-21
ndc (package): 71288-415-05
ndc (package): 71288-414-03
ndc (package): 71288-414-04
ndc (package): 71288-415-20
ndc (package): 71288-414-01
ndc (product): 71288-414
ndc (product): 71288-415
ndc11 (package): 71288041401
rxcui: 1731582
rxcui: 1731590
rxcui: 238212
spl id: 2a84682f-bf61-4eea-afdf-fcb2f1614e08
spl set id: 02541cfd-b209-49b9-a73f-13ef18dce06d
unii: V92SO9WP2I
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
GlycopyrrolateGLYCOPYRROLATEPar Health USA, LLCff65c5d3-7ba9-4315-a884-199151eb45a52026-05-14Warnings, Adverse reactionsExact identifier
unii: V92SO9WP2I
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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