Home NDC 72572-238-01 EPINEPHRINE
Product NDC 72572-238
Requested package NDC 72572-238-01
11-digit product format 725720238
Labeler code 72572
Product ID 72572-238_a9e8f660-e2e2-43f2-8596-8eed35ecb825
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 43 .
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 2026-09-14 22:38:34 2026-08 N215425-001 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD, RS 2025-03-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215425-001 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD, RS 2025-03-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215425-001 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD, RS 2025-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215425-001 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD, RS 2025-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215425-001 EPINEPHRINE 30MG/30ML (1MG/ML) SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS RLD, RS 2025-03-13 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 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 2026-09-14 22:38:34 2026-08 N215425-001 12539283 2045-01-17 Drug product 2026-02-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215425-001 12539283 2045-01-17 Drug product 2026-02-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215425-001 12539283 2045-01-17 Drug product 2026-02-05 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215425-001 12539283 2045-01-17 Drug product 2026-02-05 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 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
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 · 2 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 72572-238-01 72572023801 1 VIAL, MULTI-DOSE in 1 CARTON (72572-238-01) / 30 mL in 1 VIAL, MULTI-DOSE 2026-07-01 No No Current