Home NDC 68180-331 Ziprasidone Hydrochloride
Product NDC 68180-331
11-digit product format 681800331
Labeler code 68180
Product ID 68180-331_786d9ba6-7993-4e01-814c-f992f0d44e75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ziprasidone Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA077560
Marketing category ANDA
Marketing start 2012-03-02
Marketing end 0000-00-00
Substance ZIPRASIDONE HYDROCHLORIDE
Active strength 20 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68180-331-07 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68180-331-07 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 68180-331-07 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 68180-331-07 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 68180-331-07 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 68180-331-07 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68180-331-07 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68180-331-07 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68180-331-07 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 68180-331-07 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 68180-331-07 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 68180-331-07 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A077560-001 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2012-03-02 A077560-002 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 2012-03-02 A077560-003 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL 2012-03-02 A077560-004 ZIPRASIDONE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL 2012-03-02
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 · 176 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 2026-10-15 13:18:30 2026-09 A077560-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2012-03-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077560-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 2012-03-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077560-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL 2012-03-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A077560-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL 2012-03-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A077560-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2012-03-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077560-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 2012-03-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077560-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL 2012-03-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A077560-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL 2012-03-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A077560-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2012-03-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077560-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 2012-03-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077560-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL 2012-03-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077560-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL 2012-03-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077560-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL 2012-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077560-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL 2012-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077560-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL 2012-03-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077560-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL 2012-03-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077560-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077560-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077560-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-03-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077560-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-03-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077560-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077560-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077560-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-03-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077560-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-03-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077560-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077560-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077560-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-03-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077560-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-03-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077560-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077560-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077560-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-03-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077560-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-03-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077560-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077560-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077560-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-03-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077560-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-03-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077560-001 ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE CAPSULE / ORAL AB 2012-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077560-002 ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE CAPSULE / ORAL AB 2012-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077560-003 ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE CAPSULE / ORAL AB 2012-03-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077560-004 ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE CAPSULE / ORAL AB 2012-03-02 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 3 of 4 · 156 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ZIPRASIDONE HYDROCHLORIDE ACTIVE INGREDIENT 216X081ORU ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 ZIPRASIDONE ACTIVE MOIETY 6UKA5VEJ6X ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 GELATIN INACTIVE INGREDIENT 2G86QN327L ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 SHELLAC INACTIVE INGREDIENT 46N107B71O ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 STARCH, PREGELATINIZED CORN INACTIVE INGREDIENT O8232NY3SJ ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZIPRASIDONE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.] 9 ZIPRASIDONE HYDROCHLORIDE ACTIVE INGREDIENT 216X081ORU ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 ZIPRASIDONE ACTIVE MOIETY 6UKA5VEJ6X ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ZIPRASIDONE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP] 1
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 68180-331-07 68180033107 60 CAPSULE in 1 BOTTLE (68180-331-07) 60 capsule 2012-03-02 0000-00-00 No No Current