FDA.reportPublic FDA data

PROCHLORPERAZINE MALEATE

Product NDC
43063-742
11-digit product format
430630742
Labeler code
43063
Product ID
43063-742_51b5e4a7-7f5b-2f6f-e063-6294a90a2c02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine maleate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040268
Marketing category
ANDA
Marketing start
1998-03-01
Substance
PROCHLORPERAZINE MALEATE
Active strength
10 mg/1
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROCHLORPERAZINE MALEATE
Listing expiration
2027-12-31

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
43063-742-06PROCHLORPERAZINE MALEATE6 in 1 BOTTLE, PLASTICTABLET616
43063-742-15PROCHLORPERAZINE MALEATE15 in 1 BOTTLE, PLASTICTABLET1516

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-742-06EA - Each43063-7421813f294-49cb-4100-8fea-1c0b90fc6e2d12017-03-06
43063-742-15EA - Each43063-74298ced72c-e12a-4fd5-b045-1d059d130e0c12019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-742PROCHLORPERAZINE MALEATE TABLET [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 2 package rows20250110_fc77a504-4642-47c1-b2e3-c5db11e5816d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSNfc77a504-4642-47c1-b2e3-c5db11e5816d16
198365prochlorperazine 10 MG Oral TabletSCDfc77a504-4642-47c1-b2e3-c5db11e5816d16
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSYfc77a504-4642-47c1-b2e3-c5db11e5816d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-742-06430630742066 TABLET in 1 BOTTLE, PLASTIC (43063-742-06) 6 tablet2017-02-060000-00-00NoNoCurrent
43063-742-154306307421515 TABLET in 1 BOTTLE, PLASTIC (43063-742-15) 15 tablet2018-11-080000-00-00NoNoCurrent