FDA.reportPublic FDA data

PROCHLORPERAZINE EDISYLATE

Product NDC
23155-497
Requested package NDC
23155-497-42
11-digit product format
231550497
Labeler code
23155
Product ID
23155-497_946c01ea-378e-4a97-a646-437b6e61e3a3
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
2015-01-14
Marketing end
0000-00-00
Substance
PROCHLORPERAZINE EDISYLATE
Active strength
5 mg/mL
Pharmacologic classes
Phenothiazine [EPC],Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage23155-49723155-497-42DDiscontinued by firm2026-07-31

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204147-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAPRS2013-10-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204147-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-497-31ML - Milliliter23155-497bdfda6ee-4133-4d86-a616-8a1a9015109712015-07-20
23155-497-42ML - Milliliter23155-497d7bede80-a5ed-428e-af0f-5860e57d178712015-07-20

DailyMed Socrata Ingredients#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-497-422315504974210 VIAL in 1 PACKAGE (23155-497-42) > 2 mL in 1 VIAL (23155-497-31) 10 vial2015-01-140000-00-00NoNoCurrent