FDA.reportPublic FDA data

VASOPRESSIN

Product NDC
63323-930
11-digit product format
633230930
Labeler code
63323
Product ID
63323-930_2d123e0c-8440-410e-b3f2-c30769ad72b6
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
63323-930-00VASOPRESSIN1 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION19
63323-930-01VASOPRESSIN25 in 1 TRAYINJECTION, SOLUTION259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-930-00ML - Milliliter63323-9308d7850f3-805f-4126-bcb1-4a2cff17649c12023-07-06
63323-930-01ML - Milliliter63323-930a9551e77-6d9c-49ba-84ca-c4395487f6ca12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-930VASOPRESSIN INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]9Current NDC, 2 package rows20250309_04e0c406-6b49-4c0b-abc5-9a1a75532485.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2103182vasopressin 20 UNT in 1 mL InjectionPSN04e0c406-6b49-4c0b-abc5-9a1a755324859
21031821 ML vasopressin (USP) 20 UNT/ML InjectionSCD04e0c406-6b49-4c0b-abc5-9a1a755324859
2103182vasopressin 20 UNT per 1 ML InjectionSY04e0c406-6b49-4c0b-abc5-9a1a755324859

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63323-930-00633230930001 mL in 1 VIAL, SINGLE-DOSE1 mlHistorical
63323-930-016332309300125 VIAL, SINGLE-DOSE in 1 TRAY (63323-930-01) / 1 mL in 1 VIAL, SINGLE-DOSE (63323-930-00) 2023-05-26NoNoCurrent