FDA.reportPublic FDA data

PROCHLORPERAZINE MALEATE

Product NDC
50268-685
11-digit product format
502680685
Labeler code
50268
Product ID
50268-685_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
10 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 MALEATE10 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
50268-685-11PROCHLORPERAZINE MALEATE1 in 1 BLISTER PACKTABLET14
50268-685-15PROCHLORPERAZINE MALEATE50 in 1 BOXTABLET504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-685-11EA - Each50268-6851f75f640-700d-45c2-a67b-72e5a377b0ea12019-06-19
50268-685-15EA - Each50268-685c78e2ac0-bb07-434c-974f-3f82e929403712019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-685PROCHLORPERAZINE 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 TabletPSN45f56f93-50a7-4cd3-bce2-f97a805566516
198365prochlorperazine 10 MG Oral TabletSCD45f56f93-50a7-4cd3-bce2-f97a805566516
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY45f56f93-50a7-4cd3-bce2-f97a805566516
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
50268-685-11502680685111 in 1 BLISTER PACKHistorical
50268-685-155026806851550 BLISTER PACK in 1 BOX (50268-685-15) / 1 TABLET in 1 BLISTER PACK (50268-685-11) 50 blister pack2019-04-160000-00-00NoNoCurrent