FDA.reportPublic FDA data

PROCHLORPERAZINE MALEATE

Product NDC
68788-8708
11-digit product format
687888708
Labeler code
68788
Product ID
68788-8708_24979c05-5f42-4c42-b356-6069c2b46f8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA217478
Marketing category
ANDA
Marketing start
2024-07-01
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

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
68788-8708-1PROCHLORPERAZINE MALEATE10 in 1 BOTTLETABLET, FILM COATED102
68788-8708-2PROCHLORPERAZINE MALEATE20 in 1 BOTTLETABLET, FILM COATED202
68788-8708-3PROCHLORPERAZINE MALEATE30 in 1 BOTTLETABLET, FILM COATED302
68788-8708-5PROCHLORPERAZINE MALEATE15 in 1 BOTTLETABLET, FILM COATED152
68788-8708-6PROCHLORPERAZINE MALEATE60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8708-1EA - Each68788-8708ca23e4d2-367c-43e5-8b0e-e0c741d1c10c12024-09-09
68788-8708-2EA - Each68788-87088cf91aa4-ed0d-4e56-b112-51a48dd7d90512024-09-09
68788-8708-3EA - Each68788-87088fc7473a-363a-4245-901c-f90fc4c4674c12024-09-09
68788-8708-5EA - Each68788-8708d48bd06c-a738-476a-91c8-c9d46224ea0112024-09-09
68788-8708-6EA - Each68788-87085f99997d-24ef-4d6c-b563-8db4ab0b64c612024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8708PROCHLORPERAZINE MALEATE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20240709_f3adc8a4-2c2b-4d5e-803f-38361966cc68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSNf3adc8a4-2c2b-4d5e-803f-38361966cc682
198365prochlorperazine 10 MG Oral TabletSCDf3adc8a4-2c2b-4d5e-803f-38361966cc682
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSYf3adc8a4-2c2b-4d5e-803f-38361966cc682

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8708-16878887080110 TABLET, FILM COATED in 1 BOTTLE (68788-8708-1) 2024-07-01NoNoCurrent
68788-8708-26878887080220 TABLET, FILM COATED in 1 BOTTLE (68788-8708-2) 2024-07-01NoNoCurrent
68788-8708-36878887080330 TABLET, FILM COATED in 1 BOTTLE (68788-8708-3) 2024-07-01NoNoCurrent
68788-8708-56878887080515 TABLET, FILM COATED in 1 BOTTLE (68788-8708-5) 2024-07-01NoNoCurrent
68788-8708-66878887080660 TABLET, FILM COATED in 1 BOTTLE (68788-8708-6) 2024-07-01NoNoCurrent