FDA.reportPublic FDA data

Vasopressin

Product NDC
68083-520
11-digit product format
680830520
Labeler code
68083
Product ID
68083-520_d8e752a0-dc4e-4262-921f-133a88d89db8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vasopressin
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA216963
Marketing category
ANDA
Marketing start
2024-02-09
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, 2399907

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
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
6ac8356f-c51e-45ae-a595-aa1fad5b69a2Product name120210223
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-520-10Vasopressin10 in 1 CARTONINJECTION109
68083-520-10Vasopressin1 mL in 1 VIALINJECTION19
68083-520-25Vasopressin25 in 1 CARTONINJECTION259
68083-520-25Vasopressin1 mL in 1 VIALINJECTION19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-520VASOPRESSIN INJECTION [GLAND PHARMA LIMITED]5Current NDC, 4 package rows20240215_971f9b1c-6094-4f80-920b-cb5d7e62950a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2399907vasopressin (USP) 40 UNT in 100 ML InjectionPSN971f9b1c-6094-4f80-920b-cb5d7e62950a9
2103182vasopressin 20 UNT in 1 mL InjectionPSN971f9b1c-6094-4f80-920b-cb5d7e62950a9
21031821 ML vasopressin (USP) 20 UNT/ML InjectionSCD971f9b1c-6094-4f80-920b-cb5d7e62950a9
2399907100 ML vasopressin (USP) 0.4 UNT/ML InjectionSCD971f9b1c-6094-4f80-920b-cb5d7e62950a9
2399907vasopressin (USP) 40 UNT per 100 ML InjectionSY971f9b1c-6094-4f80-920b-cb5d7e62950a9
2103182vasopressin 20 UNT per 1 ML InjectionSY971f9b1c-6094-4f80-920b-cb5d7e62950a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68083-520-106808305201010 VIAL in 1 CARTON (68083-520-10) / 1 mL in 1 VIAL10 vial2024-02-09NoNoCurrent
68083-520-256808305202525 VIAL in 1 CARTON (68083-520-25) / 1 mL in 1 VIAL25 vial2024-02-09NoNoCurrent