FDA.reportPublic FDA data

Vasopressin in 0.9% Sodium Chloride

Product NDC
81298-8554
11-digit product format
812988554
Labeler code
81298
Product ID
81298-8554_55507afe-de33-407d-bf9d-1b916efa1518
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vasopressin
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Long Grove Pharmaceuticals, LLC
Application
NDA217766
Marketing category
NDA
Marketing start
2024-07-12
Substance
VASOPRESSIN
Active strength
.4 [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 in 0.9% Sodium Chloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VASOPRESSIN.4 [USP'U]/mL

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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81298-8554-1Vasopressin in 0.9% Sodium Chloride100 mL in 1 VIAL, SINGLE-DOSESOLUTION10010
81298-8554-3Vasopressin in 0.9% Sodium Chloride10 in 1 CARTONSOLUTION1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81298-8554-1ML - Milliliter81298-8554ef12f299-c1f4-4f91-9d35-a7aef29b9a9712026-04-20
81298-8554-3ML - Milliliter81298-85541e940a43-b6fb-4ff4-a165-a647e94a799512024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81298-8554VASOPRESSIN IN 0.9% SODIUM CHLORIDE (VASOPRESSIN) SOLUTION [LONG GROVE PHARMACEUTICALS, LLC]7Current NDC, 2 package rows20240907_bf4b0b63-0055-40d8-b331-7f9f1ea3214c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2591428vasopressin (USP) 20 UNT in 100 ML InjectionPSNbf4b0b63-0055-40d8-b331-7f9f1ea3214c10
2399907vasopressin (USP) 40 UNT in 100 ML InjectionPSNbf4b0b63-0055-40d8-b331-7f9f1ea3214c10
2591428100 ML vasopressin (USP) 0.2 UNT/ML InjectionSCDbf4b0b63-0055-40d8-b331-7f9f1ea3214c10
2399907100 ML vasopressin (USP) 0.4 UNT/ML InjectionSCDbf4b0b63-0055-40d8-b331-7f9f1ea3214c10
2591428vasopressin (USP) 0.2 UNT/ML per 100 ML InjectionSYbf4b0b63-0055-40d8-b331-7f9f1ea3214c10
2591428vasopressin (USP) 20 UNT per 100 ML InjectionSYbf4b0b63-0055-40d8-b331-7f9f1ea3214c10
2399907vasopressin (USP) 40 UNT per 100 ML InjectionSYbf4b0b63-0055-40d8-b331-7f9f1ea3214c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81298-8554-181298855401100 mL in 1 VIAL, SINGLE-DOSE100 mlHistorical
81298-8554-38129885540310 VIAL, SINGLE-DOSE in 1 CARTON (81298-8554-3) / 100 mL in 1 VIAL, SINGLE-DOSE (81298-8554-1) 2024-07-12NoNoCurrent