Vasopressin in 0.9% Sodium Chloride

Product NDC: 0338-9647
Requested package NDC: 0338-9647-12
11-digit product format: 003389647
Labeler code: 0338
Product ID: 0338-9647_e5fb5b63-6f2e-4ebe-9a55-147a793e95dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vasopressin in 0.9% Sodium Chloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA217569
Marketing category: NDA
Marketing start: 2023-09-29
Substance: VASOPRESSIN
Active strength: 40 [USP'U]/100mL
Pharmacologic classes: Decreased Diuresis [PE], Vasoconstriction [PE], Vasopressins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217569-001	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	20UNITS/100ML (0.2UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217569-002	VASOPRESSIN IN SODIUM CHLORIDE 0.9%	40UNITS/100ML (0.4UNITS/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2023-09-29	`ea1830bbd6c7…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N217569-001	12447190	2044-09-27	Drug product	2025-10-27	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N217569-002	12447190	2044-09-27	Drug product	2025-10-27	`c2088c7a36db…`
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…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Vasopressin in 0.9% Sodium Chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VASOPRESSIN	40 [USP'U]/100mL

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
2399907	Internal RxNorm lookup
2591428	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b5b2c367-6b7e-40be-a296-c4632f3e783f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99568ea8-9af8-47ab-8eb5-5730f9428dbd	Product name	1	20250625
0f6574b6-8c6c-4325-9a2b-e8f85e32ee4e	Product name	1	20250305
704c08d7-cc3f-4fb2-a29e-57130a255781	Product name	4	20241218
6ac8356f-c51e-45ae-a595-aa1fad5b69a2	Product name	1	20210223
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-9647-12	Vasopressin in 0.9% Sodium Chloride	100 mL in 1 BAG	INJECTION	100		5
0338-9647-12	Vasopressin in 0.9% Sodium Chloride	12 in 1 CARTON	INJECTION	12		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-9647-12	ML - Milliliter	0338-9647	7742321e-679b-4bdc-9e7d-60c2044e005e	1	2024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-9647	VASOPRESSIN IN 0.9% SODIUM CHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]	4	Current NDC, 2 package rows	20250306_b5b2c367-6b7e-40be-a296-c4632f3e783f.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
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 ndc (package): 0338-9647-12 ndc (product): 0338-9647 ndc11 (package): 00338964712

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y4907O6MFD	VASOPRESSIN	113-79-1	VASOPRESSIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2591428	vasopressin (USP) 20 UNT in 100 ML Injection	PSN	b5b2c367-6b7e-40be-a296-c4632f3e783f	5
2399907	vasopressin (USP) 40 UNT in 100 ML Injection	PSN	b5b2c367-6b7e-40be-a296-c4632f3e783f	5
2591428	100 ML vasopressin (USP) 0.2 UNT/ML Injection	SCD	b5b2c367-6b7e-40be-a296-c4632f3e783f	5
2399907	100 ML vasopressin (USP) 0.4 UNT/ML Injection	SCD	b5b2c367-6b7e-40be-a296-c4632f3e783f	5
2591428	vasopressin (USP) 0.2 UNT/ML per 100 ML Injection	SY	b5b2c367-6b7e-40be-a296-c4632f3e783f	5
2591428	vasopressin (USP) 20 UNT per 100 ML Injection	SY	b5b2c367-6b7e-40be-a296-c4632f3e783f	5
2399907	vasopressin (USP) 40 UNT per 100 ML Injection	SY	b5b2c367-6b7e-40be-a296-c4632f3e783f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0338-9647-12	00338964712	12 BAG in 1 CARTON (0338-9647-12) / 100 mL in 1 BAG	12 bag	2023-09-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Vasopressin in 0.9% Sodium Chloride	Baxter Healthcare Corporation	2025-02-21	HUMAN PRESCRIPTION DRUG LABEL	5