FDA.reportPublic FDA data

PROCHLORPERAZINE MALEATE

Product NDC
69452-310
11-digit product format
694520310
Labeler code
69452
Product ID
69452-310_2f9f880c-a70d-317b-e063-6294a90a2280
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA217478
Marketing category
ANDA
Marketing start
2023-09-13
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
69452-310-20PROCHLORPERAZINE MALEATE100 in 1 BOTTLETABLET, FILM COATED1002
69452-310-32PROCHLORPERAZINE MALEATE1000 in 1 BOTTLETABLET, FILM COATED10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-310-20EA - Each69452-310b9a39d25-94c0-474a-b697-499f3db426a012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-310PROCHLORPERAZINE MALEATE TABLET, FILM COATED [BIONPHARMA INC.]2Current NDC, 2 package rows20250308_052d351a-978b-6fc3-e063-6294a90aef55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN052d351a-978b-6fc3-e063-6294a90aef552
198365prochlorperazine maleate 10 MG Oral TabletPSNa826f111-4186-47d3-99c1-a72d75776c4c2
198365prochlorperazine maleate 10 MG Oral TabletPSNf3adc8a4-2c2b-4d5e-803f-38361966cc682
312635prochlorperazine maleate 5 MG Oral TabletPSN052d351a-978b-6fc3-e063-6294a90aef552
198365prochlorperazine 10 MG Oral TabletSCD052d351a-978b-6fc3-e063-6294a90aef552
198365prochlorperazine 10 MG Oral TabletSCDa826f111-4186-47d3-99c1-a72d75776c4c2
198365prochlorperazine 10 MG Oral TabletSCDf3adc8a4-2c2b-4d5e-803f-38361966cc682
312635prochlorperazine 5 MG Oral TabletSCD052d351a-978b-6fc3-e063-6294a90aef552
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY052d351a-978b-6fc3-e063-6294a90aef552
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSYa826f111-4186-47d3-99c1-a72d75776c4c2
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSYf3adc8a4-2c2b-4d5e-803f-38361966cc682
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY052d351a-978b-6fc3-e063-6294a90aef552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69452-310-2069452031020100 TABLET, FILM COATED in 1 BOTTLE (69452-310-20) 2023-09-13NoNoCurrent
69452-310-32694520310321000 TABLET, FILM COATED in 1 BOTTLE (69452-310-32) 2023-09-13NoNoCurrent