Home NDC 43066-803 epinephrine
Product NDC 43066-803
11-digit product format 430660803
Labeler code 43066
Product ID 43066-803_ef556382-9d19-4f0e-9dbe-fcecc772a3e2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name epinephrine
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Baxter Healthcare Corporation
Application NDA220626
Marketing category NDA
Marketing start 2026-03-30
Substance EPINEPHRINE
Active strength 1 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N220626-001 EPINEPHRINE EPINEPHRINE 1MG/ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD, RS 2026-03-30 N220626-002 EPINEPHRINE EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD, RS 2026-03-30
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220626-001 EPINEPHRINE 1MG/ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD, RS 2026-03-30 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N220626-002 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD, RS 2026-03-30 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base epinephrine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPINEPHRINE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YKH834O4BH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310132 Internal RxNorm lookup 1660014 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43066-803-01 epinephrine 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 1 1 43066-803-25 epinephrine 25 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 25 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43066-803-01 43066080301 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 43066-803-25 43066080325 25 VIAL, SINGLE-DOSE in 1 CARTON (43066-803-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43066-803-01) 2026-03-30 No No Current