Home NDC 80830-1659-2 EPINEPHRINE
Product NDC 80830-1659
Requested package NDC 80830-1659-2
11-digit product format 808301659
Labeler code 80830
Product ID 80830-1659_fed06ffc-e17e-4809-ad5f-92e1a815c0aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name epinephrine
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler Amneal Pharmaceuticals Private Limited
Application ANDA218208
Marketing category ANDA
Marketing start 2025-12-08
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 2026-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218208-001 EPINEPHRINE EPINEPHRINE EQ 1MG BASE/ML (EQ 1MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-12-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218208-001 AP
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 2026-02-19 14:30 UTC 2026-02 A218208-001 EPINEPHRINE EQ 1MG BASE/ML (EQ 1MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218208-001 EPINEPHRINE EQ 1MG BASE/ML (EQ 1MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-12-08 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218208-001 EPINEPHRINE EQ 1MG BASE/ML (EQ 1MG BASE/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS AP 2025-12-08 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A218208-001 AP 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218208-001 AP 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218208-001 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base EPINEPHRINE
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 80830-1659-1 EPINEPHRINE 1 mL in 1 VIAL, GLASS INJECTION 1 4 80830-1659-2 EPINEPHRINE 25 in 1 CARTON INJECTION 25 4
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 Marketing start Sample Exclude flag Status 80830-1659-2 80830165902 25 VIAL, GLASS in 1 CARTON (80830-1659-2) / 1 mL in 1 VIAL, GLASS (80830-1659-1) 2025-12-08 No No Current