PROCHLORPERAZINE EDISYLATE

Product NDC
51662-1558
11-digit product format
516621558
Labeler code
51662
Product ID
51662-1558_10358f91-4227-7e42-e063-6394a90a62de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCHLORPERAZINE EDISYLATE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA089903
Marketing category
ANDA
Marketing start
2022-06-15
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
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1558-2PROCHLORPERAZINE EDISYLATE2 mL in 1 VIALINJECTION22
51662-1558-2PROCHLORPERAZINE EDISYLATE1 in 1 POUCHINJECTION12
51662-1558-3PROCHLORPERAZINE EDISYLATE25 in 1 CASEINJECTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1558PROCHLORPERAZINE EDISYLATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 3 package rows20240228_e181c18d-32a8-587e-e053-2995a90acc5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102949prochlorperazine 5 MG/ML Injectable SolutionPSNe181c18d-32a8-587e-e053-2995a90acc5b2
2102949prochlorperazine 5 MG/ML Injectable SolutionSCDe181c18d-32a8-587e-e053-2995a90acc5b2
2102949prochlorperazine (as edisylate) 5 MG/ML Injectable SolutionSYe181c18d-32a8-587e-e053-2995a90acc5b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1558-2516621558022 mL in 1 VIAL2 mlHistorical
51662-1558-35166215580325 POUCH in 1 CASE (51662-1558-3) / 1 VIAL in 1 POUCH (51662-1558-2) / 2 mL in 1 VIAL25 pouch2022-06-150000-00-00NoNoCurrent