Home NDC 62135-991 Ziprasidone
Product NDC 62135-991
11-digit product format 621350991
Labeler code 62135
Product ID 62135-991_02591199-8759-8e40-e063-6294a90afa7f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ziprasidone
Dosage form CAPSULE
Route ORAL
Labeler Chartwell RX, LLC
Application ANDA090348
Marketing category ANDA
Marketing start 2012-09-05
Substance ZIPRASIDONE HYDROCHLORIDE
Active strength 20 mg/1
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 43 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090348-001 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-09-05 A090348-002 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-09-05 A090348-003 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-09-05 A090348-004 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-09-05
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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.
Product history page 1 of 5 · 172 observed 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 A090348-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090348-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090348-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-09-05 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090348-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-09-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090348-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090348-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090348-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-09-05 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090348-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-09-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090348-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090348-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090348-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-09-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090348-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-09-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090348-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090348-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090348-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-09-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090348-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-09-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090348-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090348-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090348-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-09-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090348-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-09-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090348-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090348-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090348-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-09-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090348-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-09-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090348-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090348-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090348-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-09-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090348-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-09-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090348-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090348-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090348-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-09-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090348-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-09-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090348-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090348-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090348-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-09-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090348-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-09-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090348-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090348-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090348-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-09-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090348-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-09-05 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 172 observed states.
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZIPRASIDONE HYDROCHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 216X081ORU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313776 Internal RxNorm lookup 313777 Internal RxNorm lookup 313778 Internal RxNorm lookup 314286 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 62135-991-60 Ziprasidone 60 in 1 BOTTLE CAPSULE 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62135-991 ZIPRASIDONE CAPSULE ZIPRASIDONE (ZIPRASIDONE) CAPSULE [CHARTWELL RX, LLC] 2 Current NDC, 1 package rows 20230808_7fbd9460-78a3-4160-9986-3a113de752a6.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 Sample Exclude flag Status 62135-991-60 62135099160 60 CAPSULE in 1 BOTTLE (62135-991-60) 60 capsule 2023-04-28 No No Current