FDA.reportPublic FDA data

Certa Dose Epinephrine Convenience Kit

Product NDC
71754-001
11-digit product format
717540001
Labeler code
71754
Product ID
71754-001_f117a6c0-1030-1c56-e053-2a95a90a6d18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epinephrine Convenience Kit
Dosage form
KIT
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
CD Acquisitions, LLC
Application
NDA204200
Marketing category
NDA
Marketing start
2018-11-26
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71754-001-012021-02-08C16284748780-1ba0f9c33-5474-a910-e053-dadaa90a0b85Epinephrine Convenience Kit NDC 71754-001 These highlights do not include all the information needed to use the Epineprhine Convenience kit safely and effectively. See full prescribing information for Epinephrine. Initial U.S. approval; 2012
71754-001-052021-02-08C16284748780-1ba0f9c33-5474-a910-e053-dadaa90a0b85Epinephrine Convenience Kit NDC 71754-001 These highlights do not include all the information needed to use the Epineprhine Convenience kit safely and effectively. See full prescribing information for Epinephrine. Initial U.S. approval; 2012
71754-001-012021-01-29C16284748780-1ba0f9c33-5474-a910-e053-dadaa90a0b85Epinephrine Convenience Kit NDC 71754-001 These highlights do not include all the information needed to use the Epineprhine Convenience kit safely and effectively. See full prescribing information for Epinephrine. Initial U.S. approval; 2012
71754-001-052021-01-29C16284748780-1ba0f9c33-5474-a910-e053-dadaa90a0b85Epinephrine Convenience Kit NDC 71754-001 These highlights do not include all the information needed to use the Epineprhine Convenience kit safely and effectively. See full prescribing information for Epinephrine. Initial U.S. approval; 2012

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-159-01Certa Dose Epinephrine Convenience Kit1 mL in 1 VIALINJECTION1 mL1 mg in 1mL9
71754-001-01Certa Dose Epinephrine Convenience Kit1 in 1 KITKIT19
71754-001-05Certa Dose Epinephrine Convenience Kit1 in 1 KITKIT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71754-001-01ML - Milliliter71754-00143d7e113-3e55-499c-b821-5f55d16d626512021-08-05
71754-001-05ML - Milliliter71754-001864ff0ee-b270-4156-be29-c0eaa5df712712021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71754-001CERTA DOSE EPINEPHRINE CONVENIENCE KIT (EPINEPHRINE CONVENIENCE KIT) KIT [CD ACQUISITIONS, LLC]9Legacy NDC, 3 package rows20250101_780ca016-d85c-6fac-e053-2a91aa0abd0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1660016Adrenalin 1 MG in 1 ML InjectionPSN780ca016-d85c-6fac-e053-2a91aa0abd0b9
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN780ca016-d85c-6fac-e053-2a91aa0abd0b9
16600161 ML epinephrine 1 MG/ML Injection [Adrenalin]SBD780ca016-d85c-6fac-e053-2a91aa0abd0b9
16600141 ML epinephrine 1 MG/ML InjectionSCD780ca016-d85c-6fac-e053-2a91aa0abd0b9
16600161 ML Adrenalin 1 MG/ML InjectionSY780ca016-d85c-6fac-e053-2a91aa0abd0b9
1660016Adrenalin 1 MG per 1 ML InjectionSY780ca016-d85c-6fac-e053-2a91aa0abd0b9
1660014epinephrine 1 MG per 1 ML InjectionSY780ca016-d85c-6fac-e053-2a91aa0abd0b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-159-01420230159011 mL in 1 VIAL1 mlHistorical
71754-001-01717540001011 KIT in 1 KIT (71754-001-01) * 1 mL in 1 VIAL (42023-159-01) 1 kit2018-11-260000-00-00NoNoCurrent
71754-001-05717540001051 KIT in 1 KIT (71754-001-05) * 1 mL in 1 VIAL (42023-159-01) 1 kit2018-11-260000-00-00NoNoCurrent