Prochlorperazine

Product NDC
54348-989
11-digit product format
543480989
Labeler code
54348
Product ID
54348-989_eaa6022b-bb02-9383-e053-2995a90abe88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCHLORPERAZINE
Dosage form
TABLET
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA040268
Marketing category
ANDA
Marketing start
2019-07-11
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE MALEATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1T8O1JTL6
Rxcui312635

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
54348-989-06Prochlorperazine6 in 1 BOTTLETABLET62
54348-989-06Prochlorperazine1 in 1 BOXTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-989PROCHLORPERAZINE TABLET [PHARMPAK, INC.]2Current NDC, Legacy NDC, 2 package rows20221011_383744db-ba57-478a-8041-2ecc26d3e1ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312635prochlorperazine maleate 5 MG Oral TabletPSN383744db-ba57-478a-8041-2ecc26d3e1ec2
312635prochlorperazine 5 MG Oral TabletSCD383744db-ba57-478a-8041-2ecc26d3e1ec2
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY383744db-ba57-478a-8041-2ecc26d3e1ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-989-06543480989061 BOTTLE in 1 BOX (54348-989-06) / 6 TABLET in 1 BOTTLE1 bottle2019-07-110000-00-00NoNoCurrent