FDA.reportPublic FDA data

Prochlorperazine Edisylate

Product NDC
72572-580
11-digit product format
725720580
Labeler code
72572
Product ID
72572-580_7395a535-b3fc-4bb8-b2e1-d8c42b9a0509
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Edisylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA089903
Marketing category
ANDA
Marketing start
2019-11-18
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

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 Identifiers#

Field, Values table
FieldValues
UniiPG20W5VQZS
Rxcui314192

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfe4595-32b8-9175-3af8-875e9c4c0538Product name620260305
7335ddeb-6cbd-135c-487d-96fa4587ad65Product name620250331
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72572-580-01Prochlorperazine Edisylate2 mL in 1 VIALINJECTION23
72572-580-25Prochlorperazine Edisylate25 in 1 CARTONINJECTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-580-01ML - Milliliter72572-580bce9e02e-bd7d-4bef-b31d-1e097e8ec02112019-12-10
72572-580-25ML - Milliliter72572-5805c2ab401-1499-42bf-bce9-3d2adb30a6bb12019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-580PROCHLORPERAZINE EDISYLATE INJECTION [CIVICA, INC.]3Current NDC, Legacy NDC, 2 package rows20250130_e3e0c6c5-6b92-40e0-a926-29c64846be93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314192prochlorperazine 10 MG in 2 ML InjectionPSNe3e0c6c5-6b92-40e0-a926-29c64846be933
3141922 ML prochlorperazine 5 MG/ML InjectionSCDe3e0c6c5-6b92-40e0-a926-29c64846be933
314192prochlorperazine 10 MG (as prochlorperazine edisylate) per 2 ML InjectionSYe3e0c6c5-6b92-40e0-a926-29c64846be933
314192prochlorperazine 10 MG per 2 ML InjectionSYe3e0c6c5-6b92-40e0-a926-29c64846be933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-580-01725720580012 mL in 1 VIAL2 mlHistorical
72572-580-257257205802525 VIAL in 1 CARTON (72572-580-25) / 2 mL in 1 VIAL (72572-580-01) 25 vial2019-11-180000-00-00NoNoCurrent