FDA.reportPublic FDA data

Compro

Product NDC
55289-119
11-digit product format
552890119
Labeler code
55289
Product ID
55289-119_30c7c9fd-e624-97a7-e063-6294a90ad3a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCHLORPERAZINE
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040246
Marketing category
ANDA
Marketing start
2000-09-01
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
Compro
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYHP6YLT61T
Rxcui198159, 284254

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
55289-119-02Compro2 in 1 BOTTLE, PLASTICSUPPOSITORY216
55289-119-06Compro6 in 1 BOTTLE, PLASTICSUPPOSITORY616

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-119-02EA - Each55289-1195ba60eb2-4031-414d-9155-bec64aaac65912012-07-24
55289-119-06EA - Each55289-119234e358b-a6b7-42b7-8494-4fe4d2aa944b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROCHLORPERAZINEACTIVE INGREDIENTYHP6YLT61TCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5
PROCHLORPERAZINEACTIVE MOIETYYHP6YLT61TCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4COMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5
HYDROGENATED COCONUT OILINACTIVE INGREDIENTJY81OXM1OMCOMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5
PALM KERNEL OILINACTIVE INGREDIENTB0S90M0233COMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-119COMPRO (PROCHLORPERAZINE) SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 2 package rows20250322_b23b67eb-78b7-48eb-84ff-c95d3ce8683c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
284254Compro 25 MG Rectal SuppositoryPSNb23b67eb-78b7-48eb-84ff-c95d3ce8683c16
198159prochlorperazine 25 MG Rectal SuppositoryPSNb23b67eb-78b7-48eb-84ff-c95d3ce8683c16
284254prochlorperazine 25 MG Rectal Suppository [Compro]SBDb23b67eb-78b7-48eb-84ff-c95d3ce8683c16
198159prochlorperazine 25 MG Rectal SuppositorySCDb23b67eb-78b7-48eb-84ff-c95d3ce8683c16
284254Compro 25 MG Rectal SuppositorySYb23b67eb-78b7-48eb-84ff-c95d3ce8683c16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-119-02552890119022 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-119-02) 2 suppository2010-12-220000-00-00NoNoCurrent
55289-119-04552890119044 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-119-04) 4 suppository2010-12-220000-00-00NoNoCurrent
55289-119-06552890119066 SUPPOSITORY in 1 BOTTLE, PLASTIC (55289-119-06) 6 suppository2023-01-18NoNoCurrent