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

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 Identifiers#

Field, Values table
FieldValues
UniiPG20W5VQZS
Rxcui2102949

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 vial2026-04-08NoNoHistorical
65145-119-256514501192525 VIAL in 1 CARTON (65145-119-25) > 2 mL in 1 VIAL (65145-119-01) 25 vial2021-05-030000-00-00NoNoCurrent