FDA.reportPublic FDA data

prochlorperazine edisylate

Product NDC
70121-1580
11-digit product format
701211580
Labeler code
70121
Product ID
70121-1580_b2472628-fee8-47a2-b345-6e95911a99b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
prochlorperazine edisylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA214192
Marketing category
ANDA
Marketing start
2022-12-12
Substance
PROCHLORPERAZINE EDISYLATE
Active strength
5 mg/mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
prochlorperazine edisylate
Listing expiration
2027-12-31

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
70121-1580-1prochlorperazine edisylate2 mL in 1 VIALINJECTION27
70121-1580-5prochlorperazine edisylate25 in 1 CARTONINJECTION257
70121-1580-7prochlorperazine edisylate10 in 1 CARTONINJECTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1580-1ML - Milliliter70121-15800852700b-ebe6-454b-8290-b0d4025c9a7712023-04-07
70121-1580-5ML - Milliliter70121-1580760e94ca-a796-4335-a380-6eeaf579562c12023-04-07
70121-1580-7ML - Milliliter70121-158049f1a709-7bf0-414d-82fb-5fb77886d78a12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1580PROCHLORPERAZINE EDISYLATE INJECTION [AMNEAL PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 3 package rows20231228_e913d678-7a5d-4e74-9e9c-1b9a3affd265.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102949prochlorperazine 5 MG/ML Injectable SolutionPSNe913d678-7a5d-4e74-9e9c-1b9a3affd2657
2102949prochlorperazine 5 MG/ML Injectable SolutionSCDe913d678-7a5d-4e74-9e9c-1b9a3affd2657
2102949prochlorperazine (as edisylate) 5 MG/ML Injectable SolutionSYe913d678-7a5d-4e74-9e9c-1b9a3affd2657

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1580-1701211580012 mL in 1 VIAL2 mlHistorical
70121-1580-57012115800525 VIAL in 1 CARTON (70121-1580-5) / 2 mL in 1 VIAL (70121-1580-1) 25 vial2022-12-120000-00-00NoNoCurrent
70121-1580-77012115800710 VIAL in 1 CARTON (70121-1580-7) / 2 mL in 1 VIAL (70121-1580-1) 10 vial2022-12-120000-00-00NoNoCurrent