FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
VASOPRESSIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VASOPRESSIN20 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY4907O6MFD
Rxcui2103182

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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
6ac8356f-c51e-45ae-a595-aa1fad5b69a2Product name120210223
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65219-039-00VASOPRESSIN1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION12
65219-039-01VASOPRESSIN25 in 1 TRAYINJECTION, SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-039-00ML - Milliliter65219-03960f96f22-a2bc-4712-9865-d4163371ceb212023-09-05
65219-039-01ML - Milliliter65219-039b077f11c-ce76-4168-893c-7f79bed7290c12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-039VASOPRESSIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]2Current NDC, 2 package rows20250309_50aef1e8-0a70-466d-93cd-c1b9ed489839.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2103182vasopressin 20 UNT in 1 mL InjectionPSN50aef1e8-0a70-466d-93cd-c1b9ed4898392
21031821 ML vasopressin (USP) 20 UNT/ML InjectionSCD50aef1e8-0a70-466d-93cd-c1b9ed4898392
2103182vasopressin 20 UNT per 1 ML InjectionSY50aef1e8-0a70-466d-93cd-c1b9ed4898392

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65219-039-00652190039001 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
65219-039-016521900390125 VIAL, SINGLE-DOSE in 1 TRAY (65219-039-01) / 1 mL in 1 VIAL, SINGLE-DOSE (65219-039-00) 2023-05-26NoNoHistorical