FDA.reportPublic FDA data

Vasostrict

Product NDC
42023-237
11-digit product format
420230237
Labeler code
42023
Product ID
42023-237_5686729a-7e3c-48da-9c58-bbdb604c56fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vasopressin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Par Health USA, LLC
Application
NDA204485
Marketing category
NDA
Marketing start
2021-12-15
Substance
VASOPRESSIN, UNSPECIFIED
Active strength
.2 [USP'U]/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vasostrict
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VASOPRESSIN, UNSPECIFIED.2 [USP'U]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY87Y826H08
Rxcui313578, 1593738, 2103182, 2103184, 2399907, 2399909, 2591428, 2591431, 2670680, 2670683

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
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
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
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-237-01Vasostrict100 mL in 1 VIALINJECTION10049
42023-237-10Vasostrict10 in 1 CARTONINJECTION1049

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-237-01ML - Milliliter42023-237b988a98b-c762-4f6c-8379-b55069082cd612022-03-09
42023-237-10ML - Milliliter42023-2377124f9aa-b422-433c-ba3a-8c7c08c857c212022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Vasopressin, UnspecifiedACTIVE INGREDIENTY87Y826H08VASOSTRICT (VASOPRESSIN) INJECTION [PAR PHARMACEUTICAL, INC.]5
Vasopressin, UnspecifiedACTIVE MOIETYY87Y826H08VASOSTRICT (VASOPRESSIN) INJECTION [PAR PHARMACEUTICAL, INC.]5
Acetic acidINACTIVE INGREDIENTQ40Q9N063PVASOSTRICT (VASOPRESSIN) INJECTION [PAR PHARMACEUTICAL, INC.]5
ChlorobutanolINACTIVE INGREDIENTHM4YQM8WRCVASOSTRICT (VASOPRESSIN) INJECTION [PAR PHARMACEUTICAL, INC.]5
WaterINACTIVE INGREDIENT059QF0KO0RVASOSTRICT (VASOPRESSIN) INJECTION [PAR PHARMACEUTICAL, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-237VASOSTRICT (VASOPRESSIN) INJECTION [ENDO USA, INC.]43Current NDC, Legacy NDC, 2 package rows20240425_b1147beb-743e-4c62-8927-91192447f8b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2591428vasopressin (USP) 20 UNT in 100 ML InjectionPSNb1147beb-743e-4c62-8927-91192447f8b849
2399907vasopressin (USP) 40 UNT in 100 ML InjectionPSNb1147beb-743e-4c62-8927-91192447f8b849
2670680vasopressin (USP) 50 UNT in 50 ML InjectionPSNb1147beb-743e-4c62-8927-91192447f8b849
2103182vasopressin 20 UNT in 1 mL InjectionPSNb1147beb-743e-4c62-8927-91192447f8b849
313578vasopressin 20 UNT/ML Injectable SolutionPSNb1147beb-743e-4c62-8927-91192447f8b849
2103184Vasostrict 20 UNT in 1 mL InjectionPSNb1147beb-743e-4c62-8927-91192447f8b849
2591431Vasostrict 20 UNT in 100 ML InjectionPSNb1147beb-743e-4c62-8927-91192447f8b849
1593738Vasostrict 20 UNT/ML Injectable SolutionPSNb1147beb-743e-4c62-8927-91192447f8b849
2399909Vasostrict 40 UNT in 100 ML InjectionPSNb1147beb-743e-4c62-8927-91192447f8b849
2670683Vasostrict 50 UNT in 50 ML InjectionPSNb1147beb-743e-4c62-8927-91192447f8b849
21031841 ML vasopressin (USP) 20 UNT/ML Injection [Vasostrict]SBDb1147beb-743e-4c62-8927-91192447f8b849
2591431100 ML vasopressin (USP) 0.2 UNT/ML Injection [Vasostrict]SBDb1147beb-743e-4c62-8927-91192447f8b849
2399909100 ML vasopressin (USP) 0.4 UNT/ML Injection [Vasostrict]SBDb1147beb-743e-4c62-8927-91192447f8b849
267068350 ML vasopressin (USP) 1 UNT/ML Injection [Vasostrict]SBDb1147beb-743e-4c62-8927-91192447f8b849
1593738vasopressin (USP) 20 UNT/ML Injectable Solution [Vasostrict]SBDb1147beb-743e-4c62-8927-91192447f8b849
21031821 ML vasopressin (USP) 20 UNT/ML InjectionSCDb1147beb-743e-4c62-8927-91192447f8b849
2591428100 ML vasopressin (USP) 0.2 UNT/ML InjectionSCDb1147beb-743e-4c62-8927-91192447f8b849
2399907100 ML vasopressin (USP) 0.4 UNT/ML InjectionSCDb1147beb-743e-4c62-8927-91192447f8b849
267068050 ML vasopressin (USP) 1 UNT/ML InjectionSCDb1147beb-743e-4c62-8927-91192447f8b849
313578vasopressin (USP) 20 UNT/ML Injectable SolutionSCDb1147beb-743e-4c62-8927-91192447f8b849
21031841 ML Vasostrict 20 UNT/ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
2591431100 ML Vasostrict 0.2 UNT/ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
2399909100 ML Vasostrict 0.4 UNT/ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
2591428vasopressin (USP) 0.2 UNT/ML per 100 ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
2670680vasopressin (USP) 1 UNT/ML per 50 ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
2591428vasopressin (USP) 20 UNT per 100 ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
2399907vasopressin (USP) 40 UNT per 100 ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
2670680vasopressin (USP) 50 UNT per 50 ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
2103182vasopressin 20 UNT per 1 ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
2670683Vasostrict 1 UNT/ML per 50 ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
2103184Vasostrict 20 UNT per 1 ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
1593738Vasostrict 20 UNT/ML Injectable SolutionSYb1147beb-743e-4c62-8927-91192447f8b849
2399909Vasostrict 40 UNT per 100 ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849
2670683Vasostrict 50 UNT per 50 ML InjectionSYb1147beb-743e-4c62-8927-91192447f8b849

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-237-0142023023701100 mL in 1 VIAL100 mlHistorical
42023-237-104202302371010 VIAL in 1 CARTON (42023-237-10) / 100 mL in 1 VIAL (42023-237-01) 10 vial2021-12-150000-00-00NoNoCurrent