Prochlorperazine Edisylate

Product NDC
23155-294
11-digit product format
231550294
Labeler code
23155
Product ID
23155-294_aa344274-7751-40fa-b8d9-3ad2c340d793
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Edisylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA204147
Marketing category
ANDA
Marketing start
2012-03-26
Substance
PROCHLORPERAZINE EDISYLATE
Active strength
5 mg/mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204147-001PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204147-001AP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-153f01610625f2…
2019-09-15 20:21 UTC2019-09A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A204147-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204147-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204147-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204147-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204147-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204147-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204147-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204147-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204147-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204147-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204147-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204147-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204147-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204147-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204147-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204147-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204147-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204147-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204147-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204147-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204147-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204147-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A204147-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204147-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204147-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204147-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A204147-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204147-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204147-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204147-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204147-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204147-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204147-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204147-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204147-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A204147-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A204147-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204147-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204147-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204147-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Prochlorperazine Edisylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE EDISYLATE5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PG20W5VQZSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2102949Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0dc48e66-6081-421b-952b-4867c9c4c794Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfe4595-32b8-9175-3af8-875e9c4c0538Product name620260305
7335ddeb-6cbd-135c-487d-96fa4587ad65Product name620250331
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-294-31Prochlorperazine Edisylate2 mL in 1 VIALINJECTION215
23155-294-41Prochlorperazine Edisylate25 in 1 PACKAGEINJECTION2515
23155-294-42Prochlorperazine Edisylate10 in 1 PACKAGEINJECTION1015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-294-31ML - Milliliter23155-294ef37af00-c699-4af3-b981-7631f880e58d12014-02-04
23155-294-41ML - Milliliter23155-2947cd52396-3879-45fe-a3c3-c71375c9b82612017-03-06
23155-294-42ML - Milliliter23155-29485b928be-a57d-47c6-8703-f5ec02aeba2812014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROCHLORPERAZINE EDISYLATEACTIVE INGREDIENTPG20W5VQZSPROCHLORPERAZINE EDISYLATE INJECTION [HERITAGE PHARMACEUTICALS INC.]4
PROCHLORPERAZINEACTIVE MOIETYYHP6YLT61TPROCHLORPERAZINE EDISYLATE INJECTION [HERITAGE PHARMACEUTICALS INC.]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPROCHLORPERAZINE EDISYLATE INJECTION [HERITAGE PHARMACEUTICALS INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROCHLORPERAZINE EDISYLATE INJECTION [HERITAGE PHARMACEUTICALS INC.]4
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWPROCHLORPERAZINE EDISYLATE INJECTION [HERITAGE PHARMACEUTICALS INC.]4
SODIUM TARTRATEINACTIVE INGREDIENTQTO9JB4MDDPROCHLORPERAZINE EDISYLATE INJECTION [HERITAGE PHARMACEUTICALS INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RPROCHLORPERAZINE EDISYLATE INJECTION [HERITAGE PHARMACEUTICALS INC.]4
PROCHLORPERAZINE EDISYLATEACTIVE INGREDIENTPG20W5VQZSPROCHLORPERAZINE EDISYLATE INJECTION [CARDINAL HEALTH]1
PROCHLORPERAZINEACTIVE MOIETYYHP6YLT61TPROCHLORPERAZINE EDISYLATE INJECTION [CARDINAL HEALTH]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPROCHLORPERAZINE EDISYLATE INJECTION [CARDINAL HEALTH]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROCHLORPERAZINE EDISYLATE INJECTION [CARDINAL HEALTH]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWPROCHLORPERAZINE EDISYLATE INJECTION [CARDINAL HEALTH]1
SODIUM TARTRATEINACTIVE INGREDIENTQTO9JB4MDDPROCHLORPERAZINE EDISYLATE INJECTION [CARDINAL HEALTH]1
WATERINACTIVE INGREDIENT059QF0KO0RPROCHLORPERAZINE EDISYLATE INJECTION [CARDINAL HEALTH]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-294PROCHLORPERAZINE EDISYLATE INJECTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 3 package rows20250410_0dc48e66-6081-421b-952b-4867c9c4c794.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECardinal Health 107, LLC6135944c-3ee2-4491-9704-33f56ad435f42025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204147
application number: ANDA204147
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0dc48e66-6081-421b-952b-4867c9c4c7942025-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204147
application number: ANDA204147
ndc (product): 23155-294
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEAvenacy Inc.fd07a1a3-c0df-4926-9964-07348e45a5fd2024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204147
application number: ANDA204147
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0338b221-db43-45c9-a829-d970fe6643ab2024-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204147
application number: ANDA204147

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102949prochlorperazine 5 MG/ML Injectable SolutionPSN0dc48e66-6081-421b-952b-4867c9c4c79415
2102949prochlorperazine 5 MG/ML Injectable SolutionSCD0dc48e66-6081-421b-952b-4867c9c4c79415
2102949prochlorperazine (as edisylate) 5 MG/ML Injectable SolutionSY0dc48e66-6081-421b-952b-4867c9c4c79415
314192prochlorperazine 10 MG in 2 ML InjectionPSN6135944c-3ee2-4491-9704-33f56ad435f411
3141922 ML prochlorperazine 5 MG/ML InjectionSCD6135944c-3ee2-4491-9704-33f56ad435f411
314192prochlorperazine 10 MG (as prochlorperazine edisylate) per 2 ML InjectionSY6135944c-3ee2-4491-9704-33f56ad435f411
314192prochlorperazine 10 MG per 2 ML InjectionSY6135944c-3ee2-4491-9704-33f56ad435f411
2102949prochlorperazine 5 MG/ML Injectable SolutionPSNc36f64fb-4087-4fea-ae92-ae83ed4bd22e6
2102949prochlorperazine 5 MG/ML Injectable SolutionSCDc36f64fb-4087-4fea-ae92-ae83ed4bd22e6
2102949prochlorperazine (as edisylate) 5 MG/ML Injectable SolutionSYc36f64fb-4087-4fea-ae92-ae83ed4bd22e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-294-31231550294312 mL in 1 VIAL2 mlHistorical
23155-294-412315502944125 VIAL in 1 PACKAGE (23155-294-41) / 2 mL in 1 VIAL (23155-294-31) 25 vial2012-03-260000-00-00NoNoCurrent
23155-294-422315502944210 VIAL in 1 PACKAGE (23155-294-42) / 2 mL in 1 VIAL (23155-294-31) 10 vial2012-03-260000-00-00NoNoCurrent