Home NDC 68083-663 Vasopressin
Product NDC 68083-663
11-digit product format 680830663
Labeler code 68083
Product ID 68083-663_d8e752a0-dc4e-4262-921f-133a88d89db8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vasopressin
Dosage form INJECTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA216963
Marketing category ANDA
Marketing start 2025-08-22
Substance VASOPRESSIN
Active strength .4 [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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216963-001 VASOPRESSIN VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 A216963-002 VASOPRESSIN IN DEXTROSE 5% VASOPRESSIN 40UNITS/100ML (0.4UNITS/ML) SOLUTION / INTRAVENOUS AP 2025-08-22
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.
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 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216963-002 VASOPRESSIN IN DEXTROSE 5% 40UNITS/100ML (0.4UNITS/ML) SOLUTION / INTRAVENOUS AP 2025-08-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216963-002 VASOPRESSIN IN DEXTROSE 5% 40UNITS/100ML (0.4UNITS/ML) SOLUTION / INTRAVENOUS AP 2025-08-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216963-001 VASOPRESSIN 20UNITS/ML (20UNITS/ML) SOLUTION / INTRAVENOUS AP 2024-02-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216963-002 VASOPRESSIN IN DEXTROSE 5% 40UNITS/100ML (0.4UNITS/ML) SOLUTION / INTRAVENOUS AP 2025-08-22 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 .4 [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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2103182 Internal RxNorm lookup 2399907 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 68083-663-10 Vasopressin 10 in 1 CARTON INJECTION 10 9 68083-663-10 Vasopressin 100 mL in 1 VIAL INJECTION 100 9
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 68083-663-10 68083066310 10 VIAL in 1 CARTON (68083-663-10) / 100 mL in 1 VIAL 10 vial 2025-08-22 No No Current