FDA.reportPublic FDA data

PROCHLORPERAZINE MALEATE

Product NDC
50268-684
11-digit product format
502680684
Labeler code
50268
Product ID
50268-684_423994fe-6cd5-476d-e063-6294a90a5814
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA040268
Marketing category
ANDA
Marketing start
2019-04-16
Substance
PROCHLORPERAZINE MALEATE
Active strength
5 mg/1
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 MALEATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE MALEATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1T8O1JTL6
Rxcui198365, 312635

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfe4595-32b8-9175-3af8-875e9c4c0538Product name620260305
7335ddeb-6cbd-135c-487d-96fa4587ad65Product name620250331
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-684-11PROCHLORPERAZINE MALEATE1 in 1 BLISTER PACKTABLET14
50268-684-15PROCHLORPERAZINE MALEATE50 in 1 BOXTABLET504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-684-11EA - Each50268-684c9f9cf8c-d6e6-45c1-a901-861ce52962f312019-06-19
50268-684-15EA - Each50268-6845a304796-84aa-4824-ae96-954ad77b19ef12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-684PROCHLORPERAZINE MALEATE TABLET PROCHLORPERAZINE MALEATE TABLET [AVPAK]2Current NDC, Legacy NDC, 2 package rows20220119_86ac7223-b840-bc0c-e053-2991aa0a32f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN86ac7223-b840-bc0c-e053-2991aa0a32f24
312635prochlorperazine maleate 5 MG Oral TabletPSN86ac7223-b840-bc0c-e053-2991aa0a32f24
198365prochlorperazine 10 MG Oral TabletSCD86ac7223-b840-bc0c-e053-2991aa0a32f24
312635prochlorperazine 5 MG Oral TabletSCD86ac7223-b840-bc0c-e053-2991aa0a32f24
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY86ac7223-b840-bc0c-e053-2991aa0a32f24
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY86ac7223-b840-bc0c-e053-2991aa0a32f24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-684-11502680684111 in 1 BLISTER PACKHistorical
50268-684-155026806841550 BLISTER PACK in 1 BOX (50268-684-15) / 1 TABLET in 1 BLISTER PACK (50268-684-11) 50 blister pack2019-04-160000-00-00NoNoCurrent