FDA.reportPublic FDA data

Epoprostenol

Product NDC
68083-642
11-digit product format
680830642
Labeler code
68083
Product ID
68083-642_8b45ebae-92d6-4a3b-a559-115c66a8352a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epoprostenol
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA219237
Marketing category
ANDA
Marketing start
2025-12-29
Substance
EPOPROSTENOL
Active strength
1.5 mg/10mL
Pharmacologic classes
Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219237-001EPOPROSTENOL SODIUMEPOPROSTENOL SODIUMEQ 0.5MG BASE/VIALINJECTABLE / INJECTIONAP22025-12-29
A219237-002EPOPROSTENOL SODIUMEPOPROSTENOL SODIUMEQ 1.5MG BASE/VIALINJECTABLE / INJECTIONAP22025-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219237-001AP2
A219237-002AP2

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A219237-001EPOPROSTENOL SODIUMEQ 0.5MG BASE/VIALINJECTABLE / INJECTIONAP22025-12-29caaa826d4ba7…
2026-08-18 06:07:402026-07A219237-002EPOPROSTENOL SODIUMEQ 1.5MG BASE/VIALINJECTABLE / INJECTIONAP22025-12-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219237-001EPOPROSTENOL SODIUMEQ 0.5MG BASE/VIALINJECTABLE / INJECTIONAP22025-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219237-002EPOPROSTENOL SODIUMEQ 1.5MG BASE/VIALINJECTABLE / INJECTIONAP22025-12-29011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219237-001EPOPROSTENOL SODIUMEQ 0.5MG BASE/VIALINJECTABLE / INJECTIONAP22025-12-29a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219237-002EPOPROSTENOL SODIUMEQ 1.5MG BASE/VIALINJECTABLE / INJECTIONAP22025-12-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A219237-001AP21caaa826d4ba7…
2026-08-18 06:07:402026-07A219237-002AP21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A219237-001AP21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A219237-002AP21011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219237-001AP21a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219237-002AP21a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Epoprostenol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPOPROSTENOL1.5 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
DCR9Z582X0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
562501Internal RxNorm lookup
562502Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
47f64fcd-cbf7-457a-9548-661fb10ff7e0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5ace20f6-48a7-4990-9c4c-3bbf62d1c730Product name220250225
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0b0b571c-056a-da12-12a1-e68fb540bb38Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-642-01Epoprostenol1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,15
68083-642-01Epoprostenol10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,105

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EpoprostenolEPOPROSTENOLGland Pharma Limited47f64fcd-cbf7-457a-9548-661fb10ff7e02026-01-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219237
application number: ANDA219237
ndc (product): 68083-642

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562501epoprostenol 0.5 MG InjectionPSN47f64fcd-cbf7-457a-9548-661fb10ff7e05
562502epoprostenol 1.5 MG InjectionPSN47f64fcd-cbf7-457a-9548-661fb10ff7e05
562501epoprostenol 0.5 MG InjectionSCD47f64fcd-cbf7-457a-9548-661fb10ff7e05
562502epoprostenol 1.5 MG InjectionSCD47f64fcd-cbf7-457a-9548-661fb10ff7e05
562501epoprostenol 0.5 MG (as epoprostenol sodium) InjectionSY47f64fcd-cbf7-457a-9548-661fb10ff7e05
562502epoprostenol 1.5 MG (as epoprostenol sodium) InjectionSY47f64fcd-cbf7-457a-9548-661fb10ff7e05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-642-01680830642011 VIAL in 1 CARTON (68083-642-01) / 10 mL in 1 VIAL1 vial2025-12-29NoNoCurrent