Home NDC 72205-205 ziprasidone mesylate
Product NDC 72205-205
11-digit product format 722050205
Labeler code 72205
Product ID 72205-205_4e003e80-c860-4b03-81e2-6662324096d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ziprasidone mesylate
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAMUSCULAR
Labeler Novadoz Pharmaceuticals LLC
Application ANDA216091
Marketing category ANDA
Marketing start 2022-09-15
Substance ZIPRASIDONE MESYLATE
Active strength 20 mg/mL
Pharmacologic classes Atypical Antipsychotic [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 42 .
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 A216091-001 ZIPRASIDONE MESYLATE ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216091-001 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 2026-08-18 06:07:40 2026-07 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216091-001 ZIPRASIDONE MESYLATE EQ 20MG BASE/VIAL POWDER / INTRAMUSCULAR AP 2022-09-15 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base ziprasidone mesylate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZIPRASIDONE MESYLATE 20 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3X6SAX83JZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 351223 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 72205-205-01 ziprasidone mesylate 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 2 72205-205-07 ziprasidone mesylate 10 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72205-205 ZIPRASIDONE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC] 1 Current NDC, Legacy NDC, 2 package rows 20220920_90b35a26-ab65-4c39-b97f-55c8c0e34b0b.zip
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 Units Marketing start Marketing end Sample Exclude flag Status 72205-205-01 72205020501 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical 72205-205-07 72205020507 10 VIAL, SINGLE-DOSE in 1 CARTON (72205-205-07) / 1 mL in 1 VIAL, SINGLE-DOSE (72205-205-01) 2022-09-15 0000-00-00 No No Current