Home NDC 65219-039 VASOPRESSIN
Product NDC 65219-039
11-digit product format 652190039
Labeler code 65219
Product ID 65219-039_9fa80e75-4058-47f2-be6f-36d33062abd6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VASOPRESSIN
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA213206
Marketing category ANDA
Marketing start 2023-05-26
Substance VASOPRESSIN
Active strength 20 [USP'U]/mL
Pharmacologic classes Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]
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 A213206-001 VASOPRESSIN VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A213206-001 AP
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 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213206-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2023-05-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base VASOPRESSIN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VASOPRESSIN 20 [USP'U]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y4907O6MFD Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2103182 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 65219-039-00 VASOPRESSIN 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 2 65219-039-01 VASOPRESSIN 25 in 1 TRAY INJECTION, SOLUTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-039 VASOPRESSIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] 2 Current NDC, 2 package rows 20250309_50aef1e8-0a70-466d-93cd-c1b9ed489839.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 · 2 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 65219-039-00 65219003900 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 65219-039-01 65219003901 25 VIAL, SINGLE-DOSE in 1 TRAY (65219-039-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-039-00) 2023-05-26 No No Current