FDA.reportPublic FDA data

prochlorperazine edisylate

Product NDC
67457-640
11-digit product format
674570640
Labeler code
67457
Product ID
67457-640_c2a1e04b-1654-456c-a66d-8ee1f877b034
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prochlorperazine edisylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA210710
Marketing category
ANDA
Marketing start
2019-04-03
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
Rxcui314192

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-640-00prochlorperazine edisylate2 mL in 1 VIALINJECTION25
67457-640-02prochlorperazine edisylate25 in 1 CARTONINJECTION255
67457-640-99prochlorperazine edisylate10 in 1 CARTONINJECTION105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-640-00ML - Milliliter67457-64006d1de81-3bd0-45d9-bab6-3a67a8f0a83712019-05-02
67457-640-02ML - Milliliter67457-64066eae783-ad3c-4f39-af88-3c334abfdf5312019-05-02
67457-640-99ML - Milliliter67457-640510a8d7a-680b-4775-b5c5-7061c42931fd12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-640PROCHLORPERAZINE EDISYLATE INJECTION [MYLAN INSTITUTIONAL LLC]5Current NDC, Legacy NDC, 3 package rows20241127_185c1647-06ea-401e-ad1d-8727d77eb827.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314192prochlorperazine 10 MG in 2 ML InjectionPSN185c1647-06ea-401e-ad1d-8727d77eb8275
3141922 ML prochlorperazine 5 MG/ML InjectionSCD185c1647-06ea-401e-ad1d-8727d77eb8275
314192prochlorperazine 10 MG (as prochlorperazine edisylate) per 2 ML InjectionSY185c1647-06ea-401e-ad1d-8727d77eb8275
314192prochlorperazine 10 MG per 2 ML InjectionSY185c1647-06ea-401e-ad1d-8727d77eb8275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67457-640-00674570640002 mL in 1 VIAL2 mlHistorical
67457-640-026745706400225 VIAL in 1 CARTON (67457-640-02) / 2 mL in 1 VIAL (67457-640-00) 25 vial2019-04-030000-00-00NoNoCurrent
67457-640-996745706409910 VIAL in 1 CARTON (67457-640-99) / 2 mL in 1 VIAL (67457-640-00) 10 vial2019-04-030000-00-00NoNoCurrent