FDA.reportPublic FDA data

Prochlorperazine Edisylate

Product NDC
65145-119
11-digit product format
651450119
Labeler code
65145
Product ID
65145-119_5b239257-b476-4705-b408-bcf1d0003305
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Edisylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Caplin Steriles Limited
Application
ANDA214379
Marketing category
ANDA
Marketing start
2026-04-08
Substance
PROCHLORPERAZINE EDISYLATE
Active strength
5 mg/mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
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 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
A214379-001PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2021-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214379-001AP

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 22:54:322026-06A214379-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2021-04-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214379-001AP1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECaplin Steriles Limited29f0e68d-4653-472d-bd86-e87a8e2cb5292026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214379
application number: ANDA214379
ndc (product): 65145-119
PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEBaxter Healthcare Corporation11cb37c7-01b4-4223-b2ea-a3695639b80b2021-04-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214379
application number: ANDA214379

Additional Listing Data#

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

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
29f0e68d-4653-472d-bd86-e87a8e2cb529Available 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
65145-119-01Prochlorperazine Edisylate2 mL in 1 VIALINJECTION26
65145-119-10Prochlorperazine Edisylate10 in 1 CARTONINJECTION106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65145-119-01ML - Milliliter65145-1196cef0eb8-5b2d-4e88-b705-bbb0188b281f12024-10-04
65145-119-10ML - Milliliter65145-119ab041121-cdbf-4f0f-9132-df7be27a51e712024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65145-119PROCHLORPERAZINE EDISYLATE INJECTION [CAPLIN STERILES LIMITED]5Current NDC, Legacy NDC, 2 package rows20241012_29f0e68d-4653-472d-bd86-e87a8e2cb529.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102949prochlorperazine 5 MG/ML Injectable SolutionPSN29f0e68d-4653-472d-bd86-e87a8e2cb5296
2102949prochlorperazine 5 MG/ML Injectable SolutionSCD29f0e68d-4653-472d-bd86-e87a8e2cb5296
2102949prochlorperazine (as edisylate) 5 MG/ML Injectable SolutionSY29f0e68d-4653-472d-bd86-e87a8e2cb5296

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65145-119-01651450119012 mL in 1 VIAL2 mlHistorical
65145-119-106514501191010 VIAL in 1 CARTON (65145-119-10) / 2 mL in 1 VIAL (65145-119-01) 10 vial2026-04-08NoNoCurrent
65145-119-256514501192525 VIAL in 1 CARTON (65145-119-25) > 2 mL in 1 VIAL (65145-119-01) 25 vial2021-05-030000-00-00NoNoCurrent