Home NDC 0338-0010 epinephrine
Product NDC 0338-0010
11-digit product format 003380010
Labeler code 0338
Product ID 0338-0010_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 2026-10-19
Substance EPINEPHRINE BITARTRATE
Active strength 32 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EPINEPHRINE BITARTRATE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-02-28 N218475-002 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EPINEPHRINE BITARTRATE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-03-16
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-02-28 c2088c7a36db…2026-10-15 13:18:30 2026-09 N218475-002 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-03-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-02-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N218475-002 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-03-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-02-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N218475-002 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-03-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-02-28 fd3edfee7708…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218475-001 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 16MG BASE/250ML (EQ 64MCG BASE/ML) SOLUTION / INTRAVENOUS RLD 2025-02-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218475-002 EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE EQ 4MG BASE/250ML (EQ 16MCG BASE/ML) SOLUTION / INTRAVENOUS RLD, RS 2026-03-16 a50c72e98297…
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 Ingredient Strength EPINEPHRINE BITARTRATE 32 ug/mL
DailyMed Product Concepts# 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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join epinephrine EPINEPHRINE Baxter Healthcare Corporation 60efd409-3555-4182-a68d-1cd7bc0d1bfc 2026-03-16 Warnings, Adverse reactions Exact identifier application applno (NDA): 218475 application number: NDA218475
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0338-0010-20 00338001020 20 BAG in 1 CARTON (0338-0010-20) / 250 mL in 1 BAG 20 bag 2026-10-19 No No Current