FDA.reportPublic FDA data

NDC 71288-427-91 - BIVALIRUDIN

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
71288-427
Requested NDC
71288-427-91
Package NDCs from labels
71288-427-91, 71288-427-92, 71288-427-10, 71288-427-11
Manufacturer
Meitheal Pharmaceuticals Inc. | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.
Effective date
2024-04-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BIVALIRUDINMeitheal Pharmaceuticals Inc. | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.2024-04-04HUMAN PRESCRIPTION DRUG LABEL
BIVALIRUDINMeitheal Pharmaceuticals Inc. | Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.2021-06-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-427-10BIVALIRUDIN5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,52
71288-427-11BIVALIRUDIN10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,102
71288-427-91BIVALIRUDIN5 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,51
71288-427-92BIVALIRUDIN10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-427BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20210610_4119b710-ef30-4e3e-b99a-38e42b4b3fca.zip
71288-427BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20240405_26fb46f6-0088-42b8-b6f2-c67224776803.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-427-10EA - Each71288-4272c2eb2b4-98e5-48ed-9ed9-c79940ba753e12021-12-08
71288-427-11EA - Each71288-42714e1f3c4-dd93-4b33-b000-272c9f47810b12021-12-08
71288-427-91EA - Each71288-42769cf98ed-2542-4c19-89ca-9732d144a98a12024-07-12
71288-427-92EA - Each71288-427fe0be6b1-59fc-401c-b3ba-42d26b01b3a312024-07-12

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
bivalirudinBIVALIRUDINSlate Run Pharmaceuticals, LLC5d9a45c6-e234-4d56-9132-5e24e65852e62021-06-09Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BIVALIRUDINBIVALIRUDINMeitheal Pharmaceuticals Inc.4119b710-ef30-4e3e-b99a-38e42b4b3fca2021-06-08Warnings, Adverse reactionsExact identifier
application number: ANDA091602
ndc (package): 71288-427-11
ndc (package): 71288-427-10
ndc (product): 71288-427
rxcui: 308769
spl id: 2b20b742-4bab-4e5b-9d1b-9a7ca9e0daf7
spl set id: 4119b710-ef30-4e3e-b99a-38e42b4b3fca
unii: TN9BEX005G
bivalirudinBIVALIRUDINSandoz Incce56f806-7845-429d-a1ce-c2dbf79b22eb2019-09-30Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINDr. Reddy's Laboratories Limited19beb2ae-6064-3c24-fe50-0cee868969792019-07-16Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G

Reported adverse events (FAERS/openFDA)#

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