Home NDC 0703-0676 Treprostinil
Product NDC 0703-0676
11-digit product format 007030676
Labeler code 0703
Product ID 0703-0676_c7be0baa-694d-498d-a474-3611f7773954
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Treprostinil
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Teva Parenteral Medicines, Inc.
Application ANDA206648
Marketing category ANDA
Marketing start 2019-09-30
Substance TREPROSTINIL
Active strength 50 mg/20mL
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 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206648-001 TREPROSTINIL TREPROSTINIL 1MG/ML INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2019-09-26 A206648-002 TREPROSTINIL TREPROSTINIL 2.5MG/ML INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2019-09-26 A206648-003 TREPROSTINIL TREPROSTINIL 5MG/ML INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2019-09-26 A206648-004 TREPROSTINIL TREPROSTINIL 10MG/ML INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2019-09-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 2026-08-01 22:54:32 2026-06 A206648-001 TREPROSTINIL 1MG/ML INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2019-09-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A206648-002 TREPROSTINIL 2.5MG/ML INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2019-09-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A206648-003 TREPROSTINIL 5MG/ML INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2019-09-26 a50c72e98297…2026-08-01 22:54:32 2026-06 A206648-004 TREPROSTINIL 10MG/ML INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2019-09-26 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Treprostinil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TREPROSTINIL 50 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination RUM6K67ESG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349407 Internal RxNorm lookup 349408 Internal RxNorm lookup 349409 Internal RxNorm lookup 349410 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 0703-0676-01 Treprostinil 1 in 1 CARTON INJECTION, SOLUTION 1 5 0703-0676-01 Treprostinil 20 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 20 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0703-0676 TREPROSTINIL INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20220624_4b2ce4aa-4302-49db-9456-c8cf0e034968.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0703-0676-01 00703067601 1 VIAL, MULTI-DOSE in 1 CARTON (0703-0676-01) / 20 mL in 1 VIAL, MULTI-DOSE 2019-09-30 0000-00-00 No No Current