FDA.reportPublic FDA data

epinephrine

Product NDC
0338-0006
11-digit product format
003380006
Labeler code
0338
Product ID
0338-0006_74cb9596-3ecd-4d54-8a27-9dc270938aac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA218475
Marketing category
NDA
Marketing start
2026-03-16
Substance
EPINEPHRINE BITARTRATE
Active strength
16 ug/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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEPINEPHRINE BITARTRATEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-02-28
N218475-002EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEPINEPHRINE BITARTRATEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2026-03-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2025-02-28fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-02-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N218475-002EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2026-03-16a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
epinephrine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE BITARTRATE16 ug/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30Q7KI53AKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2695029Internal RxNorm lookup
2707568Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
60efd409-3555-4182-a68d-1cd7bc0d1bfcAvailable on FDA.report

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
0338-0006-20epinephrine20 in 1 CARTONINJECTION, SOLUTION209
0338-0006-20epinephrine250 mL in 1 BAGINJECTION, SOLUTION2509

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
epinephrineEPINEPHRINEBaxter Healthcare Corporation60efd409-3555-4182-a68d-1cd7bc0d1bfc2026-03-16Warnings, Adverse reactionsExact identifier
application applno (NDA): 218475
application number: NDA218475
ndc (product): 0338-0006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2695029EPINEPHrine 4 MG in 250 ML InjectionPSN60efd409-3555-4182-a68d-1cd7bc0d1bfc9
2707568EPINEPHrine bitartrate 16 MG in 250 ML InjectionPSN60efd409-3555-4182-a68d-1cd7bc0d1bfc9
2695029250 ML epinephrine 0.016 MG/ML InjectionSCD60efd409-3555-4182-a68d-1cd7bc0d1bfc9
2707568250 ML epinephrine 0.064 MG/ML InjectionSCD60efd409-3555-4182-a68d-1cd7bc0d1bfc9
2707568epinephrine (as bitartrate) 16 MG per 250 ML InjectionSY60efd409-3555-4182-a68d-1cd7bc0d1bfc9
2695029epinephrine 4 MG per 250 ML InjectionSY60efd409-3555-4182-a68d-1cd7bc0d1bfc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-0006-200033800062020 BAG in 1 CARTON (0338-0006-20) / 250 mL in 1 BAG20 bag2026-03-16NoNoCurrent