Home NDC 42023-434 Adrenalin (epinephrine in sodium chloride)
Product NDC 42023-434
11-digit product format 420230434
Labeler code 42023
Product ID 42023-434_6d6942ec-d208-4ea6-9ad4-ef4b29aca966
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Epinephrine in Sodium Chloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Par Health USA, LLC
Application NDA215875
Marketing category NDA
Marketing start 2025-05-14
Substance EPINEPHRINE
Active strength 20 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 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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42023-434-10 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42023-434-10 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42023-434-10 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42023-434-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42023-434-10 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42023-434-10 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42023-434-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42023-434-10 ad56d346431e…cc804d4bbf1e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215875-001 ADRENALIN EPINEPHRINE 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 N215875-002 ADRENALIN EPINEPHRINE 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 N215875-003 ADRENALIN EPINEPHRINE 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 N215875-004 ADRENALIN EPINEPHRINE 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 N215875-005 ADRENALIN EPINEPHRINE 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21
Orange Book patents# Current patent rows page 1 of 1 · 20 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215875-001 10653646 2039-03-21 Drug product 2023-05-10 N215875-001 11083698 2039-03-21 U-3567 2023-05-10 N215875-001 11207280 2039-03-21 Drug product 2023-05-10 N215875-001 12133837 2039-03-21 Drug product 2024-11-06 N215875-002 10653646 2039-03-21 Drug product 2023-05-10 N215875-002 11083698 2039-03-21 U-3567 2023-05-10 N215875-002 11207280 2039-03-21 Drug product 2023-05-10 N215875-002 12133837 2039-03-21 Drug product 2024-11-06 N215875-003 10653646 2039-03-21 Drug product 2023-05-10 N215875-003 11083698 2039-03-21 U-3567 2023-05-10 N215875-003 11207280 2039-03-21 Drug product 2023-05-10 N215875-003 12133837 2039-03-21 Drug product 2024-11-06 N215875-004 10653646 2039-03-21 Drug product 2023-05-10 N215875-004 11083698 2039-03-21 U-3567 2023-05-10 N215875-004 11207280 2039-03-21 Drug product 2023-05-10 N215875-004 12133837 2039-03-21 Drug product 2024-11-06 N215875-005 10653646 2039-03-21 Drug product 2023-05-10 N215875-005 11083698 2039-03-21 U-3567 2023-05-10 N215875-005 11207280 2039-03-21 Drug product 2023-05-10 N215875-005 12133837 2039-03-21 Drug product 2024-11-06
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.
Product history page 1 of 3 · 110 observed 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 2026-02-19 14:30 UTC 2026-02 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215875-001 ADRENALIN 2MG/250ML (8MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215875-002 ADRENALIN 4MG/250ML (16MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215875-003 ADRENALIN 5MG/250ML (20MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215875-004 ADRENALIN 8MG/250ML (32MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215875-005 ADRENALIN 10MG/250ML (40MCG/ML) SOLUTION / INTRAVENOUS RLD, RS 2023-04-21 5bbf6a4d5a75…
Observed Orange Book patent history# Patent history page 1 of 10 · 375 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215875-001 10653646 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-001 11083698 2039-03-21 U-3567 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-001 11207280 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-001 12133837 2039-03-21 Drug product 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-002 10653646 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-002 11083698 2039-03-21 U-3567 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-002 11207280 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-002 12133837 2039-03-21 Drug product 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-003 10653646 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-003 11083698 2039-03-21 U-3567 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-003 11207280 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-003 12133837 2039-03-21 Drug product 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-004 10653646 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-004 11083698 2039-03-21 U-3567 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-004 11207280 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-004 12133837 2039-03-21 Drug product 2024-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-005 10653646 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-005 11083698 2039-03-21 U-3567 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-005 11207280 2039-03-21 Drug product 2023-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215875-005 12133837 2039-03-21 Drug product 2024-11-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-001 10653646 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-001 11083698 2039-03-21 U-3567 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-001 11207280 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-001 12133837 2039-03-21 Drug product 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-002 10653646 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-002 11083698 2039-03-21 U-3567 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-002 11207280 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-002 12133837 2039-03-21 Drug product 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-003 10653646 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-003 11083698 2039-03-21 U-3567 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-003 11207280 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-003 12133837 2039-03-21 Drug product 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-004 10653646 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-004 11083698 2039-03-21 U-3567 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-004 11207280 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-004 12133837 2039-03-21 Drug product 2024-11-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-005 10653646 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-005 11083698 2039-03-21 U-3567 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-005 11207280 2039-03-21 Drug product 2023-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215875-005 12133837 2039-03-21 Drug product 2024-11-06 31067a03dcf5…
Additional Listing Data#
Finished product Yes
Brand name base Adrenalin (epinephrine in sodium chloride)
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPINEPHRINE 20 ug/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 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2695029 Internal RxNorm lookup 2695032 Internal RxNorm lookup 2707356 Internal RxNorm lookup 2707359 Internal RxNorm lookup 2713737 Internal RxNorm lookup 2713740 Internal RxNorm lookup 2719203 Internal RxNorm lookup 2719204 Internal RxNorm lookup 2719206 Internal RxNorm lookup 2719209 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 42023-434-01 Adrenalin (epinephrine in sodium chloride) 250 mL in 1 BAG INJECTION 250 28 42023-434-10 Adrenalin (epinephrine in sodium chloride) 10 in 1 CARTON INJECTION 10 28
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 42023-434-01 42023043401 250 mL in 1 BAG 250 ml Historical 42023-434-10 42023043410 10 BAG in 1 CARTON (42023-434-10) / 250 mL in 1 BAG (42023-434-01) 10 bag 2025-05-14 No No Current