FDA.reportPublic FDA data

PROCHLORPERAZINE EDISYLATE

Product NDC
25021-790
11-digit product format
250210790
Labeler code
25021
Product ID
25021-790_18174b35-89ba-487a-bbc5-95716b8c1274
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PROCHLORPERAZINE EDISYLATE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA214107
Marketing category
ANDA
Marketing start
2021-11-15
Substance
PROCHLORPERAZINE EDISYLATE
Active strength
5 mg/mL
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 EDISYLATE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PROCHLORPERAZINE EDISYLATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPG20W5VQZS
Rxcui2102949

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9bfe4595-32b8-9175-3af8-875e9c4c0538Product name620260305
7335ddeb-6cbd-135c-487d-96fa4587ad65Product name620250331
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-790-02PROCHLORPERAZINE EDISYLATE10 in 1 CARTONINJECTION102
25021-790-02PROCHLORPERAZINE EDISYLATE2 mL in 1 VIALINJECTION22
25021-790-03PROCHLORPERAZINE EDISYLATE2 mL in 1 VIALINJECTION22
25021-790-03PROCHLORPERAZINE EDISYLATE25 in 1 CARTONINJECTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-790-02ML - Milliliter25021-790328af7d9-f9bb-4132-b43d-87eb2117f8a512022-02-07
25021-790-03ML - Milliliter25021-79079da60da-e8c4-4d34-a749-f7a0c10c2cf512022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-790PROCHLORPERAZINE EDISYLATE INJECTION [SAGENT PHARMACEUTICALS]2Current NDC, Legacy NDC, 4 package rows20221201_fed5ed29-7091-4b3c-bf67-64f32cd189bb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102949prochlorperazine 5 MG/ML Injectable SolutionPSNfed5ed29-7091-4b3c-bf67-64f32cd189bb2
2102949prochlorperazine 5 MG/ML Injectable SolutionSCDfed5ed29-7091-4b3c-bf67-64f32cd189bb2
2102949prochlorperazine (as edisylate) 5 MG/ML Injectable SolutionSYfed5ed29-7091-4b3c-bf67-64f32cd189bb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
25021-790-022502107900210 VIAL in 1 CARTON (25021-790-02) / 2 mL in 1 VIAL10 vial2021-11-150000-00-00NoNoCurrent
25021-790-032502107900325 VIAL in 1 CARTON (25021-790-03) / 2 mL in 1 VIAL25 vial2021-11-150000-00-00NoNoCurrent