Application 217569

Type: NDA
Sponsor: BAXTER HLTHCARE CORP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	VASOPRESSIN	SOLUTION;INTRAVENOUS	20UNITS/100ML (0.2UNITS/ML)	Yes	Yes
002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	VASOPRESSIN	SOLUTION;INTRAVENOUS	40UNITS/100ML (0.4UNITS/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	VASOPRESSIN	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-09-29
N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	VASOPRESSIN	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2023-09-29

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217569-001	12447190	2044-09-27		Drug product	2025-10-27
N217569-002	12447190	2044-09-27		Drug product	2025-10-27

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217569-001	12447190	2044-09-27	Drug product	2025-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217569-002	12447190	2044-09-27	Drug product	2025-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217569-001	12447190	2044-09-27	Drug product	2025-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217569-002	12447190	2044-09-27	Drug product	2025-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217569-001	12447190	2044-09-27	Drug product	2025-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217569-002	12447190	2044-09-27	Drug product	2025-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217569-001	12447190	2044-09-27	Drug product	2025-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217569-002	12447190	2044-09-27	Drug product	2025-10-27	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217569-001	12447190	2044-09-27	Drug product	2025-10-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217569-002	12447190	2044-09-27	Drug product	2025-10-27	`a50c72e98297…`

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
Vasopressin in 0.9% Sodium Chloride	VASOPRESSIN IN 0.9% SODIUM CHLORIDE	Baxter Healthcare Corporation	b5b2c367-6b7e-40be-a296-c4632f3e783f	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217569 application number: NDA217569

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81366	SUPPL	2025-02-25
81362	SUPPL	2025-02-25
77757	SUPPL	2024-03-04
77459	ORIG	2024-02-09
75664	ORIG	2023-10-03
75662	ORIG	2023-10-03