Home NDC 67457-587 EPOPROSTENOL
Product NDC 67457-587
11-digit product format 674570587
Labeler code 67457
Product ID 67457-587_2a163b77-9e01-4516-b19c-f5a12ce48560
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name EPOPROSTENOL
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA213913
Marketing category ANDA
Marketing start 2024-09-25
Substance EPOPROSTENOL
Active strength .5 mg/10mL
Pharmacologic classes Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
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 42 .
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 A213913-001 EPOPROSTENOL SODIUM EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 A213913-002 EPOPROSTENOL SODIUM EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-08-18 06:07:40 2026-07 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 1e350fbaab3a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213913-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213913-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2024-06-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base EPOPROSTENOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPOPROSTENOL .5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination DCR9Z582X0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 562501 Internal RxNorm lookup 562502 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 67457-587-10 EPOPROSTENOL 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 1 67457-587-10 EPOPROSTENOL 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-587 EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC] 1 Current NDC, 2 package rows 20241004_2a163b77-9e01-4516-b19c-f5a12ce48560.zip
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 67457-587-10 67457058710 1 VIAL in 1 CARTON (67457-587-10) / 10 mL in 1 VIAL 1 vial 2024-09-25 No No Current