Prochlorperazine Edisylate

Product NDC
55150-360
11-digit product format
551500360
Labeler code
55150
Product ID
55150-360_5287e3a1-7470-4fd2-a9ea-acddf25ee83e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Edisylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Eugia US LLC
Application
ANDA213873
Marketing category
ANDA
Marketing start
2022-07-14
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
Rxcui2102949

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55150-360-01Prochlorperazine Edisylate1 in 1 CARTONINJECTION14
55150-360-01Prochlorperazine Edisylate2 mL in 1 VIAL, MULTI-DOSEINJECTION24
55150-360-25Prochlorperazine Edisylate2 mL in 1 VIAL, MULTI-DOSEINJECTION24
55150-360-25Prochlorperazine Edisylate25 in 1 CARTONINJECTION254

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55150-360-01ML - Milliliter55150-360e0893439-35ff-4f31-8aad-217eaeb4335012023-01-09
55150-360-25ML - Milliliter55150-360c0664c77-8f03-4067-b19f-a579ecdfa7c612022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55150-360PROCHLORPERAZINE EDISYLATE INJECTION [EUGIA US LLC]4Current NDC, Legacy NDC, 4 package rows20241121_24358d03-d06d-4946-8ebd-a62bc15d33c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102949prochlorperazine 5 MG/ML Injectable SolutionPSN24358d03-d06d-4946-8ebd-a62bc15d33c04
2102949prochlorperazine 5 MG/ML Injectable SolutionSCD24358d03-d06d-4946-8ebd-a62bc15d33c04
2102949prochlorperazine (as edisylate) 5 MG/ML Injectable SolutionSY24358d03-d06d-4946-8ebd-a62bc15d33c04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55150-360-01551500360011 VIAL, MULTI-DOSE in 1 CARTON (55150-360-01) / 2 mL in 1 VIAL, MULTI-DOSE2022-07-140000-00-00NoNoCurrent
55150-360-255515003602525 VIAL, MULTI-DOSE in 1 CARTON (55150-360-25) / 2 mL in 1 VIAL, MULTI-DOSE2022-07-140000-00-00NoNoCurrent