FDA.reportPublic FDA data

NDC 0781-3440-71 - COSYNTROPIN

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
0781-3440
Requested NDC
0781-3440-71
Package NDCs from labels
0781-3440-71, 0781-3440-95
Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2024-02-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
COSYNTROPIN - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-02-22HUMAN PRESCRIPTION DRUG LABEL
Cosyntropin - Sandoz IncSandoz Inc2024-01-10HUMAN PRESCRIPTION DRUG LABEL
Cosyntropin - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-11-03HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-05-02Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3440-71Cosyntropin1 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,16
0781-3440-95Cosyntropin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3440COSYNTROPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]5Current NDC, Legacy NDC, 2 package rows20240531_1342169c-e214-4f22-8363-1fd45b85d1e8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3440-71EA - Each0781-3440cae9d48d-f388-4f22-ab42-52849ed0ab0312013-05-02
0781-3440-95EA - Each0781-34401d5e734a-7aa8-4585-ab85-1b63b772420612013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COSYNTROPINACTIVE INGREDIENT72YY86EA29COSYNTROPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]1
COSYNTROPINACTIVE MOIETY72YY86EA29COSYNTROPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACOSYNTROPIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC]1

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 1 ยท 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
CortrosynCOSYNTROPINAmphastar Pharmaceuticals, Inc.746856e9-3930-4f6a-b8e6-a03845d6dd0b2025-01-30Warnings, Adverse reactionsExact identifier
unii: 72YY86EA29
CortrosynCOSYNTROPINMedical Purchasing Solutions, LLC15eaaab2-d656-7310-e063-6394a90ae59f2024-04-12Adverse reactionsExact identifier
unii: 72YY86EA29
COSYNTROPINCOSYNTROPINHF Acquisition Co LLC, DBA HealthFirstc6cf2223-4a93-0b28-e053-2a95a90ade532024-02-22Adverse reactionsExact identifier
application number: ANDA202147
ndc (package): 51662-1567-1
ndc (product): 51662-1567
spl id: 120401a8-c1c7-581c-e063-6294a90a94f8
spl set id: c6cf2223-4a93-0b28-e053-2a95a90ade53
unii: 72YY86EA29
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
CosyntropinCOSYNTROPINSandoz Inc1342169c-e214-4f22-8363-1fd45b85d1e82024-01-10Warnings, Adverse reactionsExact identifier
application number: ANDA202147
ndc (package): 0781-3440-95
ndc (package): 0781-3440-71
ndc (product): 0781-3440
ndc11 (package): 00781344071
spl id: 7e07a53d-7214-4471-859f-059d66318106
spl set id: 1342169c-e214-4f22-8363-1fd45b85d1e8
unii: 72YY86EA29
CosyntropinCOSYNTROPINMedical Purchasing Solutions, LLC09441f78-7350-0cb3-e063-6394a90a46ab2023-11-03Adverse reactionsExact identifier
application number: ANDA202147
ndc (package): 71872-7313-1
ndc (product): 71872-7313
spl id: 094426f5-3a15-37e5-e063-6394a90aa985
spl set id: 09441f78-7350-0cb3-e063-6394a90a46ab
unii: 72YY86EA29
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

Reported adverse events (FAERS/openFDA)#

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