Home NDC 62756-060 epoprostenol
Product NDC 62756-060
11-digit product format 627560060
Labeler code 62756
Product ID 62756-060_fae129b5-c1b5-45f2-864c-eee72f289334
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name epoprostenol
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA210473
Marketing category ANDA
Marketing start 2021-01-16
Substance EPOPROSTENOL SODIUM
Active strength 1.5 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 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 62756-060-40 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 62756-060-40 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 62756-060-40 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 A210473-001 EPOPROSTENOL SODIUM EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 A210473-002 EPOPROSTENOL SODIUM EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15
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.
Product history page 1 of 2 · 72 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 2026-08-18 06:07:40 2026-07 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 RS 2021-01-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210473-001 EPOPROSTENOL SODIUM EQ 0.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210473-002 EPOPROSTENOL SODIUM EQ 1.5MG BASE/VIAL INJECTABLE / INJECTION AP2 2021-01-15 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base epoprostenol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPOPROSTENOL SODIUM 1.5 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4K04IQ1OF4 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62756-060-40 epoprostenol 10 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 10 6 62756-060-40 epoprostenol 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62756-060 EPOPROSTENOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20250425_db57e498-db20-45e8-8298-b0cf0811d270.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 Marketing end Sample Exclude flag Status 62756-060-40 62756006040 1 VIAL in 1 CARTON (62756-060-40) / 10 mL in 1 VIAL 1 vial 2021-01-16 0000-00-00 No No Current