Home NDC 72485-430 Ziprasidone Mesylate 20 mg/mL
Product NDC 72485-430
11-digit product format 724850430
Labeler code 72485
Product ID 72485-430_aae33647-bd18-4cbb-b264-bb8e17ad91c2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ziprasidone Mesylate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Armas Pharmaceuticals Inc.
Application ANDA217595
Marketing category ANDA
Marketing start 2026-09-21
Substance ZIPRASIDONE MESYLATE
Active strength 20 mg/mL
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A217595-001 ZIPRASIDONE MESYLATE ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2025-09-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217595-001 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 A217595-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2025-09-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217595-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2025-09-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217595-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2025-09-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217595-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2025-09-03 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217595-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2025-09-03 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 Ziprasidone Mesylate 20 mg/mL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZIPRASIDONE MESYLATE 20 mg/mL
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72485-430-10 72485043010 10 VIAL, SINGLE-DOSE in 1 CARTON (72485-430-10) / 1 mL in 1 VIAL, SINGLE-DOSE (72485-430-01) 2026-09-21 No No Current