Home NDC 72572-238 EPINEPHRINE
Product NDC 72572-238
11-digit product format 725720238
Labeler code 72572
Product ID 72572-238_4a79ad00-405b-4454-a692-7f1daac4adec
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EPINEPHRINE
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler CIVICA, INC.
Application NDA215425
Marketing category NDA
Marketing start 2025-03-13
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215425-001 EPINEPHRINE EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD, RS 2025-03-13
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215425-001 12539283 2045-01-17 Drug product 2026-02-05
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 2026-08-01 22:54:32 2026-06 N215425-001 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD, RS 2025-03-13 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N215425-001 12539283 2045-01-17 Drug product 2026-02-05 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310132 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 72572-238-01 EPINEPHRINE 30 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION, CONCENTRATE 30 1 72572-238-01 EPINEPHRINE 1 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 1 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72572-238-01 72572023801 1 VIAL, MULTI-DOSE in 1 CARTON (72572-238-01) / 30 mL in 1 VIAL, MULTI-DOSE 2025-03-13 No No Current