FDA.reportPublic FDA data

Prochlorperazine Edisylate

Product NDC
72266-204
11-digit product format
722660204
Labeler code
72266
Product ID
72266-204_24fdbe72-a9c4-6144-e063-6394a90ac10d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Edisylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
FOSUN PHARMA USA INC
Application
ANDA214107
Marketing category
ANDA
Marketing start
2023-05-01
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
A214107-001PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2021-09-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214107-001AP

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 22:54:322026-06A214107-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTIONAP2021-09-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A214107-001AP1a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEFOSUN PHARMA USA INCf793cdb3-9fd8-79e1-e053-6394a90ae08b2024-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214107
application number: ANDA214107
ndc (product): 72266-204
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEGland Pharma Limiteda0fd3d58-7470-4d0f-9e6c-84e92c02a97f2024-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214107
application number: ANDA214107
PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATESagent Pharmaceuticalsfed5ed29-7091-4b3c-bf67-64f32cd189bb2022-11-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214107
application number: ANDA214107

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
f793cdb3-9fd8-79e1-e053-6394a90ae08bAvailable 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
a6ffe0a0-7823-b305-75e9-2a5c6f2be4acProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-204-01Prochlorperazine Edisylate2 mL in 1 VIALINJECTION24
72266-204-10Prochlorperazine Edisylate10 in 1 CARTONINJECTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-204-10ML - Milliliter72266-2041ccd2b61-1ced-4b4e-a6e5-fa83778a867d12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-204PROCHLORPERAZINE EDISYLATE INJECTION [FOSUN PHARMA USA INC]4Current NDC, 2 package rows20250323_f793cdb3-9fd8-79e1-e053-6394a90ae08b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2102949prochlorperazine 5 MG/ML Injectable SolutionPSNf793cdb3-9fd8-79e1-e053-6394a90ae08b4
2102949prochlorperazine 5 MG/ML Injectable SolutionSCDf793cdb3-9fd8-79e1-e053-6394a90ae08b4
2102949prochlorperazine (as edisylate) 5 MG/ML Injectable SolutionSYf793cdb3-9fd8-79e1-e053-6394a90ae08b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72266-204-01722660204012 mL in 1 VIAL2 mlHistorical
72266-204-107226602041010 VIAL in 1 CARTON (72266-204-10) / 2 mL in 1 VIAL (72266-204-01) 10 vial2023-05-01NoNoCurrent