FDA.reportPublic FDA data

epinephrine

Product NDC
0338-0006
Requested package NDC
0338-0006-20
11-digit product format
003380006
Labeler code
0338
Product ID
0338-0006_cdf8a0ef-38b7-4e08-8496-942ac752ebe3
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 44.

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
2026-10-15 13:18:302026-09N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-02-28c2088c7a36db…
2026-10-15 13:18:302026-09N218475-002EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2026-03-16c2088c7a36db…
2026-09-14 22:38:342026-08N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-02-2884e616aacf4f…
2026-09-14 22:38:342026-08N218475-002EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2026-03-1684e616aacf4f…
2026-08-18 06:07:402026-07N218475-001EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 16MG BASE/250ML (EQ 64MCG BASE/ML)SOLUTION / INTRAVENOUSRLD2025-02-28caaa826d4ba7…
2026-08-18 06:07:402026-07N218475-002EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDEEQ 4MG BASE/250ML (EQ 16MCG BASE/ML)SOLUTION / INTRAVENOUSRLD, RS2026-03-16caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

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

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

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

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