ziprasidone

Product NDC
55111-258
11-digit product format
551110258
Labeler code
55111
Product ID
55111-258_7eaaea2d-4068-4a22-c7f5-c4ac01d418a1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ziprasidone
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA077565
Marketing category
ANDA
Marketing start
2012-03-02
Substance
ZIPRASIDONE HYDROCHLORIDE
Active strength
60 mg/1
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 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077565-001ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02
A077565-002ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02
A077565-003ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02
A077565-004ZIPRASIDONE HYDROCHLORIDEZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A077565-001AB
A077565-002AB
A077565-003AB
A077565-004AB

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-001ZIPRASIDONE HYDROCHLORIDEEQ 20MG BASECAPSULE / ORALAB2012-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-002ZIPRASIDONE HYDROCHLORIDEEQ 40MG BASECAPSULE / ORALAB2012-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-003ZIPRASIDONE HYDROCHLORIDEEQ 60MG BASECAPSULE / ORALAB2012-03-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-004ZIPRASIDONE HYDROCHLORIDEEQ 80MG BASECAPSULE / ORALAB2012-03-02d8e5a09893c0…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077565-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077565-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077565-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077565-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077565-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077565-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077565-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077565-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077565-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077565-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077565-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077565-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077565-004AB1d8e5a09893c0…

Additional Listing Data#

Finished product
Yes
Brand name base
ziprasidone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZIPRASIDONE HYDROCHLORIDE60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
216X081ORUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313776Internal RxNorm lookup
313777Internal RxNorm lookup
313778Internal RxNorm lookup
314286Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
396cb4a6-01a1-f73f-2a37-39df9067bf98Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
defe29d6-6a09-c3aa-4400-b1130380ccc3Product name520231206
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-258-01ziprasidone100 in 1 BOTTLECAPSULE10025
55111-258-05ziprasidone500 in 1 BOTTLECAPSULE50025
55111-258-30ziprasidone30 in 1 BOTTLECAPSULE3025
55111-258-60ziprasidone60 in 1 BOTTLECAPSULE6025
55111-258-78ziprasidone10 in 1 CARTONCAPSULE1025
55111-258-78ziprasidone10 in 1 BLISTER PACKCAPSULE1025
55111-258-81ziprasidone10 in 1 BLISTER PACKCAPSULE1025
55111-258-81ziprasidone3 in 1 CARTONCAPSULE325
55111-258-90ziprasidone90 in 1 BOTTLECAPSULE9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-258-60EA - Each55111-258399b8f5e-3af3-416a-993e-46fcd41cd96512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ziprasidone hydrochlorideACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ziprasidoneACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
alcoholINACTIVE INGREDIENT3K9958V90MZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ammoniaINACTIVE INGREDIENT5138Q19F1XZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ferric oxide redINACTIVE INGREDIENT1K09F3G675ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
gelatinINACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
isopropyl alcoholINACTIVE INGREDIENTND2M416302ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
magnesium stearateINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
povidone k30INACTIVE INGREDIENTU725QWY32XZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
propylene glycolINACTIVE INGREDIENT6DC9Q167V3ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
shellacINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
starch, cornINACTIVE INGREDIENTO8232NY3SJZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]7
ZIPRASIDONE HYDROCHLORIDEACTIVE INGREDIENT216X081ORUZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
ZIPRASIDONEACTIVE MOIETY6UKA5VEJ6XZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
1-PROPOXY-2-PROPANOLINACTIVE INGREDIENT152BY1743WZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
GELATININACTIVE INGREDIENT2G86QN327LZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
PHENOXYISOPROPANOLINACTIVE INGREDIENT87CZY0NY1AZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
SHELLACINACTIVE INGREDIENT46N107B71OZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZIPRASIDONE HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-258ZIPRASIDONE CAPSULE [DR. REDDY'S LABORATORIES LIMITED]22Current NDC, Legacy NDC, 9 package rows20241128_396cb4a6-01a1-f73f-2a37-39df9067bf98.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ziprasidoneZIPRASIDONEREMEDYREPACK INC.6665279a-32ab-43ce-a258-039a6779a1a22026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidoneZIPRASIDONEREMEDYREPACK INC.3834670f-cc31-4ed9-87ec-b631339ae18a2026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack5d576819-cd14-4a61-8a2f-6b90d8eac07e2026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidoneZIPRASIDONEREMEDYREPACK INC.48b54613-9b5f-4fcb-ba1f-22085ee0d8d12026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ZiprasidoneZIPRASIDONEMajor Pharmaceuticalsca55c149-5b9a-4144-b586-37cb5e84dc4e2026-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidoneZIPRASIDONEDr. Reddy's Laboratories Limited396cb4a6-01a1-f73f-2a37-39df9067bf982026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ndc (product): 55111-258
ziprasidoneZIPRASIDONENorthStar Rx LLC0071a228-21cc-56a6-dcc9-a7a6ceea758c2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEREMEDYREPACK INC.56370be6-42a2-4962-acdc-22b7c6e0e7fe2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack14191e0d-8219-4f6e-b808-09c4804a82622026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fc9ffbc3-1f16-9265-e053-6294a90acfd22025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565
ziprasidone hydrochlorideZIPRASIDONE HYDROCHLORIDEBryant Ranch Prepack48e6e141-66d3-4eab-b0bf-dfd1d44b48322023-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077565
application number: ANDA077565

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313777ziprasidone HCl 60 MG Oral CapsulePSN5d576819-cd14-4a61-8a2f-6b90d8eac07e100
313777ziprasidone 60 MG Oral CapsuleSCD5d576819-cd14-4a61-8a2f-6b90d8eac07e100
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSY5d576819-cd14-4a61-8a2f-6b90d8eac07e100
314286ziprasidone HCl 20 MG Oral CapsulePSNca55c149-5b9a-4144-b586-37cb5e84dc4e10
313776ziprasidone HCl 40 MG Oral CapsulePSNca55c149-5b9a-4144-b586-37cb5e84dc4e10
313777ziprasidone HCl 60 MG Oral CapsulePSNca55c149-5b9a-4144-b586-37cb5e84dc4e10
313778ziprasidone HCl 80 MG Oral CapsulePSNca55c149-5b9a-4144-b586-37cb5e84dc4e10
314286ziprasidone 20 MG Oral CapsuleSCDca55c149-5b9a-4144-b586-37cb5e84dc4e10
313776ziprasidone 40 MG Oral CapsuleSCDca55c149-5b9a-4144-b586-37cb5e84dc4e10
313777ziprasidone 60 MG Oral CapsuleSCDca55c149-5b9a-4144-b586-37cb5e84dc4e10
313778ziprasidone 80 MG Oral CapsuleSCDca55c149-5b9a-4144-b586-37cb5e84dc4e10
314286ziprasidone (as ziprasidone HCl monohydrate) 20 MG Oral CapsuleSYca55c149-5b9a-4144-b586-37cb5e84dc4e10
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSYca55c149-5b9a-4144-b586-37cb5e84dc4e10
313776ziprasidone (as ziprasidone hydrochloride monohydrate) 40 MG Oral CapsuleSYca55c149-5b9a-4144-b586-37cb5e84dc4e10
313778ziprasidone (as ziprasidone hydrochloride monohydrate) 80 MG Oral CapsuleSYca55c149-5b9a-4144-b586-37cb5e84dc4e10
313777ziprasidone HCl 60 MG Oral CapsulePSN48b54613-9b5f-4fcb-ba1f-22085ee0d8d13
313777ziprasidone 60 MG Oral CapsuleSCD48b54613-9b5f-4fcb-ba1f-22085ee0d8d13
313777ziprasidone (as ziprasidone HCl monohydrate) 60 MG Oral CapsuleSY48b54613-9b5f-4fcb-ba1f-22085ee0d8d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-258-0155111025801100 CAPSULE in 1 BOTTLE (55111-258-01) 100 capsule2012-03-020000-00-00NoNoCurrent
55111-258-0555111025805500 CAPSULE in 1 BOTTLE (55111-258-05) 500 capsule2012-03-020000-00-00NoNoCurrent
55111-258-305511102583030 CAPSULE in 1 BOTTLE (55111-258-30) 30 capsule2012-03-020000-00-00NoNoCurrent
55111-258-605511102586060 CAPSULE in 1 BOTTLE (55111-258-60) 60 capsule2012-03-020000-00-00NoNoCurrent
55111-258-785511102587810 BLISTER PACK in 1 CARTON (55111-258-78) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2012-03-020000-00-00NoNoCurrent
55111-258-81551110258813 BLISTER PACK in 1 CARTON (55111-258-81) / 10 CAPSULE in 1 BLISTER PACK3 blister pack2012-03-020000-00-00NoNoCurrent
55111-258-905511102589090 CAPSULE in 1 BOTTLE (55111-258-90) 90 capsule2012-03-020000-00-00NoNoCurrent