FDA.reportPublic FDA data

Prochlorperazine Edisylate

Product NDC
0713-0351
11-digit product format
007130351
Labeler code
0713
Product ID
0713-0351_284f182c-9dde-805f-e063-6394a90a0f02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Edisylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA213626
Marketing category
ANDA
Marketing start
2022-02-11
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213626-001PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2021-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A213626-001AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A213626-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2021-09-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A213626-001AP1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECosette Pharmaceuticals, Inc.4687b9f5-2d67-4fe0-af4d-2415a42b52922024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213626
application number: ANDA213626
ndc (product): 0713-0351

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PG20W5VQZSInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2102949Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4687b9f5-2d67-4fe0-af4d-2415a42b5292Available on FDA.report

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
0713-0351-02Prochlorperazine Edisylate2 mL in 1 VIALINJECTION23
0713-0351-09Prochlorperazine Edisylate10 in 1 PACKAGEINJECTION103
0713-0351-25Prochlorperazine Edisylate25 in 1 PACKAGEINJECTION253

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0351-02ML - Milliliter0713-03515b1f8ce4-ac8b-4449-b32a-184ca7f8f55b12022-03-09
0713-0351-09ML - Milliliter0713-03510ca166c1-94c9-4130-8f33-5a5125f2b1c412022-03-09
0713-0351-25ML - Milliliter0713-035153ae3503-8442-4efd-8a90-673b1bc95a8312022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0351PROCHLORPERAZINE EDISYLATE INJECTION [COSETTE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 3 package rows20241204_4687b9f5-2d67-4fe0-af4d-2415a42b5292.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102949prochlorperazine 5 MG/ML Injectable SolutionPSN4687b9f5-2d67-4fe0-af4d-2415a42b52923
2102949prochlorperazine 5 MG/ML Injectable SolutionSCD4687b9f5-2d67-4fe0-af4d-2415a42b52923
2102949prochlorperazine (as edisylate) 5 MG/ML Injectable SolutionSY4687b9f5-2d67-4fe0-af4d-2415a42b52923

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0351-02007130351022 mL in 1 VIAL2 mlHistorical
0713-0351-090071303510910 VIAL in 1 PACKAGE (0713-0351-09) / 2 mL in 1 VIAL (0713-0351-02) 10 vial2022-02-110000-00-00NoNoCurrent
0713-0351-250071303512525 VIAL in 1 PACKAGE (0713-0351-25) / 2 mL in 1 VIAL (0713-0351-02) 25 vial2022-02-110000-00-00NoNoCurrent