Geodon

Product NDC
0049-1203
11-digit product format
000491203
Labeler code
0049
Product ID
0049-1203_6f13378f-ffe4-440e-aca4-73b0ffa9e552
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone mesylate
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAMUSCULAR
Labeler
Roerig
Application
NDA020919
Marketing category
NDA
Marketing start
2017-07-24
Marketing end
0000-00-00
Substance
ZIPRASIDONE MESYLATE
Active strength
20 mg/mL
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0049-1203DDiscontinued by firm2026-08-10
excluded packagepackage0049-12030049-1203-10DDiscontinued by firm2026-08-10

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0049-1203-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0049-1203-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0049-1203-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0049-1203-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0049-1203-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0049-1203-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0049-1203-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0049-1203-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0049-1203-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0049-1203-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0049-1203-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0049-1203-10557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020919-001GEODONZIPRASIDONE MESYLATEEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020919-001AP

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARRLD, RS2002-06-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-2187673890dc5c…
2021-03-12 10:30 UTC2021-03N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARAPRLD, RS2002-06-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARRLD, RS2002-06-213f01610625f2…
2019-09-15 20:21 UTC2019-09N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARRLD, RS2002-06-21b00525d2431f…
2019-07-19 19:46 UTC2019-07N020919-001GEODONEQ 20MG BASE/MLINJECTABLE / INTRAMUSCULARRLD, RS2002-06-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-213f0d92c62455…
2023-05-13 08:27 UTC2023-05N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21053a50430f4f…
2023-01-26 05:58 UTC2023-01N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020919-001GEODONEQ 20MG BASE/VIALPOWDER / INTRAMUSCULARAPRLD, RS2002-06-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020919-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020919-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020919-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020919-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020919-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020919-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020919-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020919-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020919-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020919-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020919-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020919-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020919-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020919-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020919-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020919-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020919-001AP14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03N020919-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020919-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020919-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03N020919-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020919-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020919-001AP1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020919-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020919-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020919-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020919-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020919-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020919-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020919-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020919-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020919-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020919-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020919-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020919-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020919-001AP1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020919-001AP1a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0049-1203-01EA - Each0049-1203ffd0075e-047c-4746-bfed-8963704d209412017-08-11
0049-1203-10EA - Each0049-12037e090b3b-402a-4ff0-994c-2face7f7ec3512017-08-11

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GeodonZIPRASIDONEViatris Specialty LLCa2b4cc65-6a6d-49c4-adfc-a4458562a1672025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020919
application number: NDA020919
GeodonZIPRASIDONE HYDROCHLORIDEROERIG8326928a-2cb6-4f7f-9712-03a425a14c372025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020919
application number: NDA020919

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0049-1203-100004912031010 CARTON in 1 CARTON (0049-1203-10) > 1 VIAL, SINGLE-DOSE in 1 CARTON (0049-1203-01) > 1 mL in 1 VIAL, SINGLE-DOSE10 carton2017-07-240000-00-00NoNoCurrent