FDA.reportPublic FDA data

NDC 16729-275-03 - 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
16729-275
Requested NDC
16729-275-03
Package NDCs from labels
16729-275-03, 16729-275-67
Manufacturer
Accord Healthcare, Inc. | Intas Pharmaceuticals Limited
Effective date
2024-08-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bivalirudin - Accord Healthcare, Inc. | Intas Pharmaceuticals LimitedAccord Healthcare, Inc. | Intas Pharmaceuticals Limited2024-08-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-275-03Bivalirudin5 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,57
16729-275-67Bivalirudin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-275BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.]7Current NDC, Legacy NDC, 2 package rows20240816_c20969cb-72d4-469b-9bd8-332250d896c3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-275-03EA - Each16729-275a65d4a70-faf6-4761-a8fd-3e345e1756d712018-12-13
16729-275-67EA - Each16729-275800e179c-9749-4a97-9a52-04d3e863cd3712018-12-13

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 1 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BivalirudinBIVALIRUDINAvenacy, LLC42aa2630-83d6-433d-8277-0f672cf8d71d2026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BIVALIRUDINBIVALIRUDINEugia US LLCe574d04f-67b4-4a84-9d66-8c2d54f951202026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
bivalirudinBIVALIRUDINCivica, Inc.19a4afc5-151d-4d3c-bfef-48aa8797d6952025-09-10Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINFresenius Kabi USA, LLC50975be1-6d1f-497c-b989-1825a0fae1a72025-08-27Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
BivalirudinBIVALIRUDINFresenius Kabi USA, LLCaf943fa0-ab0f-4b62-9ff0-54ee24cdb7722025-05-08Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINMylan Institutional LLC95d150e7-f152-4091-b831-e469c9578a542025-03-24Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINHainan Shuangcheng Pharmaceuticals Co., Ltd.61de12ff-e280-4bab-9804-43869ec45fa72024-12-23Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINAccord Healthcare, Inc.c20969cb-72d4-469b-9bd8-332250d896c32024-08-15Warnings, Adverse reactionsExact identifier
application number: ANDA206551
ndc (package): 16729-275-03
ndc (package): 16729-275-67
ndc (product): 16729-275
ndc11 (package): 16729027503
rxcui: 308769
spl id: 1fbdba30-8018-d7d3-e063-6294a90ae6b6
spl set id: c20969cb-72d4-469b-9bd8-332250d896c3
unii: TN9BEX005G
BivalirudinBIVALIRUDINMAIA Pharmaceuticals, Inc.c727199d-f4cd-4658-8fdf-568590beface2024-05-27Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
BIVALIRUDINBIVALIRUDINMeitheal Pharmaceuticals Inc.26fb46f6-0088-42b8-b6f2-c672247768032024-04-04Warnings, Adverse reactionsExact identifier
rxcui: 308769
unii: TN9BEX005G
BivalirudinBIVALIRUDINPar Health USA, LLC91cf9d00-29e0-4357-a184-f70026c47edb2024-03-01Warnings, Adverse reactionsExact identifier
unii: TN9BEX005G
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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