FDA.reportPublic FDA data

Vasopressin in 0.9% Sodium Chloride

Product NDC
0338-9647
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vasopressin in 0.9% Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VASOPRESSIN40 [USP'U]/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY4907O6MFD
Rxcui2399907, 2591428

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99568ea8-9af8-47ab-8eb5-5730f9428dbdProduct name120250625
0f6574b6-8c6c-4325-9a2b-e8f85e32ee4eProduct name120250305
704c08d7-cc3f-4fb2-a29e-57130a255781Product name420241218
6ac8356f-c51e-45ae-a595-aa1fad5b69a2Product name120210223
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0338-9647-12Vasopressin in 0.9% Sodium Chloride100 mL in 1 BAGINJECTION1005
0338-9647-12Vasopressin in 0.9% Sodium Chloride12 in 1 CARTONINJECTION125

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0338-9647-12ML - Milliliter0338-96477742321e-679b-4bdc-9e7d-60c2044e005e12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-9647VASOPRESSIN IN 0.9% SODIUM CHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION]4Current NDC, 2 package rows20250306_b5b2c367-6b7e-40be-a296-c4632f3e783f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2591428vasopressin (USP) 20 UNT in 100 ML InjectionPSNb5b2c367-6b7e-40be-a296-c4632f3e783f5
2399907vasopressin (USP) 40 UNT in 100 ML InjectionPSNb5b2c367-6b7e-40be-a296-c4632f3e783f5
2591428100 ML vasopressin (USP) 0.2 UNT/ML InjectionSCDb5b2c367-6b7e-40be-a296-c4632f3e783f5
2399907100 ML vasopressin (USP) 0.4 UNT/ML InjectionSCDb5b2c367-6b7e-40be-a296-c4632f3e783f5
2591428vasopressin (USP) 0.2 UNT/ML per 100 ML InjectionSYb5b2c367-6b7e-40be-a296-c4632f3e783f5
2591428vasopressin (USP) 20 UNT per 100 ML InjectionSYb5b2c367-6b7e-40be-a296-c4632f3e783f5
2399907vasopressin (USP) 40 UNT per 100 ML InjectionSYb5b2c367-6b7e-40be-a296-c4632f3e783f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-9647-120033896471212 BAG in 1 CARTON (0338-9647-12) / 100 mL in 1 BAG12 bag2023-09-29NoNoCurrent