ANGIOTENSIN II

Product NDC
68083-553
11-digit product format
680830553
Labeler code
68083
Product ID
68083-553_db7a3372-cd0e-412e-a8e2-90b5fdcf3e3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ANGIOTENSIN II
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Gland Pharma Limited
Application
ANDA216966
Marketing category
ANDA
Marketing start
2025-06-03
Substance
ANGIOTENSIN II
Active strength
2.5 mg/mL
Pharmacologic classes
Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANGIOTENSIN II2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiM089EFU921
Rxcui1999007

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
130a1d32-6dfa-469f-904c-6e21cbf0f11cProduct name220260317

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-553-01ANGIOTENSIN II1 in 1 CARTONINJECTION13
68083-553-01ANGIOTENSIN II1 mL in 1 VIAL, SINGLE-DOSEINJECTION13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1999007angiotensin II 2.5 MG in 1 ML InjectionPSN727d1102-fc46-46f8-b78e-fd13f0738fe43
19990071 ML angiotensin II 2.5 MG/ML InjectionSCD727d1102-fc46-46f8-b78e-fd13f0738fe43
1999007angiotensin II 2.5 MG per 1 ML InjectionSY727d1102-fc46-46f8-b78e-fd13f0738fe43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68083-553-01680830553011 VIAL, SINGLE-DOSE in 1 CARTON (68083-553-01) / 1 mL in 1 VIAL, SINGLE-DOSE2025-06-03NoNoHistorical