FDA.reportPublic FDA data

EPINEPHRINE

Product NDC
51662-1221
Requested package NDC
51662-1221-1
11-digit product format
516621221
Labeler code
51662
Product ID
51662-1221_ba994a2d-ea6f-7d72-e053-2a95a90ab16e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPINEPHRINE
Dosage form
INJECTION, SOLUTION
Route
ENDOTRACHEAL; INTRACARDIAC; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-09-17
Marketing end
0000-00-00
Substance
EPINEPHRINE
Active strength
0 mg/mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA],Adrenergic beta-Agonists [MoA],alpha-Adrenergic Agonist [EPC],beta-Adrenergic Agonist [EPC],Catecholamine [EPC],Catecholamines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage51662-122151662-1221-1IInactivated 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 packagepackage51662-122151662-1221-1EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51662-122151662-1221-1EExcluded 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51662-1221-12020-02-07C16284748780-19d75b9cf-e0ed-f424-e053-dadaa90a57ceEPINEPHRINE INJECTION, USP 1mg/10mL (0.1mg/mL) SYR (1:10,000)
51662-1221-12020-01-31C16284748780-19d75b9cf-e0ed-f424-e053-dadaa90a57ceEPINEPHRINE INJECTION, USP 1mg/10mL (0.1mg/mL) SYR (1:10,000)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1221-1EPINEPHRINE10 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION105
51662-1221-1EPINEPHRINE1 in 1 CARTONINJECTION, SOLUTION15
51662-1221-2EPINEPHRINE1 mL in 1 POUCHINJECTION, SOLUTION15
51662-1221-3EPINEPHRINE50 in 1 CASEINJECTION, SOLUTION505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1221EPINEPHRINE INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Legacy NDC, 4 package rows20210206_761a3ad5-c6ad-67c8-e053-2991aa0a42dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727373EPINEPHrine 1 MG in 10 ML Prefilled SyringePSN761a3ad5-c6ad-67c8-e053-2991aa0a42dd5
72737310 ML epinephrine 0.1 MG/ML Prefilled SyringeSCD761a3ad5-c6ad-67c8-e053-2991aa0a42dd5
727373epinephrine 1 MG per 10 ML Prefilled SyringeSY761a3ad5-c6ad-67c8-e053-2991aa0a42dd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51662-1221-1516621221011 SYRINGE, GLASS in 1 CARTON (51662-1221-1) > 10 mL in 1 SYRINGE, GLASS2018-09-170000-00-00NoNoCurrent