Home NDC 43825-200 Terlivaz
Product NDC 43825-200
11-digit product format 438250200
Labeler code 43825
Product ID 43825-200_1d0832a2-debc-40bf-8bbe-59383d0bd3c6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Terlipressin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Mallinckrodt Hospital Products Inc.
Application NDA022231
Marketing category NDA
Marketing start 2022-09-14
Substance TERLIPRESSIN
Active strength .85 mg/5mL
Pharmacologic classes Vasopressin Receptor Agonist [EPC], Vasopressin Receptor Agonists [MoA]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022231-001 TERLIVAZ TERLIPRESSIN ACETATE EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14
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 N022231-001 10335452 2037-04-05 U-3711 2023-10-25
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N022231-001 NCE 2027-09-14 N022231-001 ODE-406 2029-09-14
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 2026-02-19 14:30 UTC 2026-02 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022231-001 TERLIVAZ EQ 0.85MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2022-09-14 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 2026-02-19 14:30 UTC 2026-02 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 a72a2bbeb626…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022231-001 10335452 2037-04-05 U-3711 2023-10-25 a50c72e98297…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Terlivaz
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TERLIPRESSIN .85 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7Z5X49W53P Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2612431 Internal RxNorm lookup 2612436 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 43825-200-01 Terlivaz 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 6 43825-200-01 Terlivaz 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43825-200 TERLIVAZ (TERLIPRESSIN) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MALLINCKRODT HOSPITAL PRODUCTS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240420_3a35b86c-f451-4fac-8499-43019e4da354.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Terlivaz TERLIPRESSIN Mallinckrodt Hospital Products Inc. 3a35b86c-f451-4fac-8499-43019e4da354 2026-06-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022231 application number: NDA022231 ndc (product): 43825-200
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 43825-200-01 43825020001 1 VIAL, SINGLE-DOSE in 1 CARTON (43825-200-01) / 5 mL in 1 VIAL, SINGLE-DOSE 2022-09-14 0000-00-00 No No Current