FDA.reportPublic FDA data

EPINEPHRINE

Product NDC
51662-1381
Requested package NDC
51662-1381-3
11-digit product format
516621381
Labeler code
51662
Product ID
51662-1381_e651aebd-f61a-c3a6-e053-2995a90aea01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPINEPHRINE
Dosage form
INJECTION
Route
INTRACARDIAC; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-08-15
Marketing end
0000-00-00
Substance
EPINEPHRINE
Active strength
0 mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage51662-138151662-1381-3IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51662-138151662-1381-3EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51662-138151662-1381-3EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1381-1EPINEPHRINE1 in 1 CARTONINJECTION11
51662-1381-1EPINEPHRINE10 mL in 1 VIALINJECTION101
51662-1381-2EPINEPHRINE1 in 1 POUCHINJECTION11
51662-1381-2EPINEPHRINE1 in 1 BOXINJECTION11
51662-1381-3EPINEPHRINE10 in 1 CASEINJECTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1381EPINEPHRINE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]1Legacy NDC, 2 package rows20210206_ba8c02aa-7f61-6cf3-e053-2a95a90aa71e.zip
51662-1381EPINEPHRINE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]1Legacy NDC, 3 package rows20220817_e651aebd-f619-c3a6-e053-2995a90aea01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727373EPINEPHrine 1 MG in 10 ML Prefilled SyringePSNba8c02aa-7f61-6cf3-e053-2a95a90aa71e1
727373EPINEPHrine 1 MG in 10 ML Prefilled SyringePSNe651aebd-f619-c3a6-e053-2995a90aea011
72737310 ML epinephrine 0.1 MG/ML Prefilled SyringeSCDba8c02aa-7f61-6cf3-e053-2a95a90aa71e1
72737310 ML epinephrine 0.1 MG/ML Prefilled SyringeSCDe651aebd-f619-c3a6-e053-2995a90aea011
727373epinephrine 1 MG per 10 ML Prefilled SyringeSYba8c02aa-7f61-6cf3-e053-2a95a90aa71e1
727373epinephrine 1 MG per 10 ML Prefilled SyringeSYe651aebd-f619-c3a6-e053-2995a90aea011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1381-35166213810310 POUCH in 1 CASE (51662-1381-3) > 1 BOX in 1 POUCH (51662-1381-2) > 1 VIAL in 1 BOX > 10 mL in 1 VIAL10 pouch2022-08-150000-00-00NoNoCurrent