Home NDC 68083-553-01 ANGIOTENSIN II
Product NDC 68083-553
Requested package NDC 68083-553-01
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216966-001 ANGIOTENSIN ll ACETATE ANGIOTENSIN II ACETATE EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2025-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216966-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A216966-001 ANGIOTENSIN ll ACETATE EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2025-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216966-001 ANGIOTENSIN ll ACETATE EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2025-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216966-001 ANGIOTENSIN ll ACETATE EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2025-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216966-001 ANGIOTENSIN ll ACETATE EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2025-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216966-001 ANGIOTENSIN ll ACETATE EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2025-06-03 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216966-001 ANGIOTENSIN ll ACETATE EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) SOLUTION / INTRAVENOUS AP 2025-06-03 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ANGIOTENSIN II
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANGIOTENSIN II 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M089EFU921 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1999007 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68083-553-01 ANGIOTENSIN II 1 in 1 CARTON INJECTION 1 3 68083-553-01 ANGIOTENSIN II 1 mL in 1 VIAL, SINGLE-DOSE INJECTION 1 3
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68083-553-01 68083055301 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-553-01) / 1 mL in 1 VIAL, SINGLE-DOSE 2025-06-03 No No Current