FDA.reportPublic FDA data

Prochlorperazine

Product NDC
0713-0135
11-digit product format
007130135
Labeler code
0713
Product ID
0713-0135_462a6c34-db6d-8d31-e063-6294a90ae196
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA040058
Marketing category
ANDA
Marketing start
1993-11-30
Substance
PROCHLORPERAZINE
Active strength
25 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
PROCHLORPERAZINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYHP6YLT61T
Rxcui198159

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
0713-0135-10Prochlorperazine1 in 1 BLISTER PACKSUPPOSITORY110
0713-0135-10Prochlorperazine1000 in 1 CARTONSUPPOSITORY100010
0713-0135-12Prochlorperazine1 in 1 BLISTER PACKSUPPOSITORY110
0713-0135-12Prochlorperazine12 in 1 CARTONSUPPOSITORY1210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0135-10EA - Each0713-0135e00681ee-89cf-4c16-b364-e165eb0bc1e712013-02-13
0713-0135-12EA - Each0713-01354c4b09ed-acdd-40b2-8794-9ec83a02b3d112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ProchlorperazineACTIVE INGREDIENTYHP6YLT61TPROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]4
ProchlorperazineACTIVE MOIETYYHP6YLT61TPROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]4
glycerinINACTIVE INGREDIENTPDC6A3C0OXPROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]4
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4PROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]4
Hydrogenated Coconut OilINACTIVE INGREDIENTJY81OXM1OMPROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]4
Palm Kernel OilINACTIVE INGREDIENTB0S90M0233PROCHLORPERAZINE (PROCHLORPERAZINE) SUPPOSITORY [G&W LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0135PROCHLORPERAZINE SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20231130_9595346e-76e5-e155-341b-ffaaafb885ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198159prochlorperazine 25 MG Rectal SuppositoryPSN85e774cd-4e55-4c2b-872d-0d7602862ede15
198159prochlorperazine 25 MG Rectal SuppositorySCD85e774cd-4e55-4c2b-872d-0d7602862ede15
198159prochlorperazine 25 MG Rectal SuppositoryPSN9595346e-76e5-e155-341b-ffaaafb885ab10
198159prochlorperazine 25 MG Rectal SuppositorySCD9595346e-76e5-e155-341b-ffaaafb885ab10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0135-10007130135101000 BLISTER PACK in 1 CARTON (0713-0135-10) / 1 SUPPOSITORY in 1 BLISTER PACK1000 blister pack1993-11-300000-00-00NoNoCurrent
0713-0135-120071301351212 BLISTER PACK in 1 CARTON (0713-0135-12) / 1 SUPPOSITORY in 1 BLISTER PACK12 blister pack1993-11-300000-00-00NoNoCurrent