Prochlorperazine Maleate

Product NDC
70771-1697
11-digit product format
707711697
Labeler code
70771
Product ID
70771-1697_d31d30de-9869-4ded-bb4d-c3b2ecbec440
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA216495
Marketing category
ANDA
Marketing start
2022-08-10
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 Maleate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE MALEATE5 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
70771-1697-1Prochlorperazine Maleate100 in 1 BOTTLETABLET1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1697PROCHLORPERAZINE MALEATE TABLET [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 1 package rows20241207_1e7fd1f5-c9cc-45a2-8974-4e0ceab8406c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198365prochlorperazine maleate 10 MG Oral TabletPSN1e7fd1f5-c9cc-45a2-8974-4e0ceab8406c4
312635prochlorperazine maleate 5 MG Oral TabletPSN1e7fd1f5-c9cc-45a2-8974-4e0ceab8406c4
198365prochlorperazine 10 MG Oral TabletSCD1e7fd1f5-c9cc-45a2-8974-4e0ceab8406c4
312635prochlorperazine 5 MG Oral TabletSCD1e7fd1f5-c9cc-45a2-8974-4e0ceab8406c4
198365prochlorperazine (as prochlorperazine maleate) 10 MG Oral TabletSY1e7fd1f5-c9cc-45a2-8974-4e0ceab8406c4
312635prochlorperazine 5 MG (as prochlorperazine maleate) Oral TabletSY1e7fd1f5-c9cc-45a2-8974-4e0ceab8406c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1697-170771169701100 TABLET in 1 BOTTLE (70771-1697-1) 100 tablet2022-08-100000-00-00NoNoCurrent