FDA.reportPublic FDA data

Prochlorperazine Edisylate

Product NDC
14789-700
11-digit product format
147890700
Labeler code
14789
Product ID
14789-700_6abe6979-1fee-47d6-a8c1-0943adcd2b10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prochlorperazine Edisylate
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Nexus Pharmaceuticals Inc.
Application
ANDA204860
Marketing category
ANDA
Marketing start
2019-02-25
Marketing end
0000-00-00
Substance
PROCHLORPERAZINE EDISYLATE
Active strength
5 mg/mL
Pharmacologic classes
Phenothiazine [EPC], Phenothiazines [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct14789-700DDiscontinued by firm2026-07-31
excluded packagepackage14789-70014789-700-02DDiscontinued by firm2026-07-31

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
A204860-001PROCHLORPERAZINE EDISYLATEPROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTION2019-02-15

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 22:54:322026-06A204860-001PROCHLORPERAZINE EDISYLATEEQ 5MG BASE/MLINJECTABLE / INJECTION2019-02-15a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
14789-700-02ML - Milliliter14789-70016be9a23-8319-483b-81b3-f67b38fa769512019-03-12
14789-700-07ML - Milliliter14789-7004bd3e65e-810c-4ec4-b4dd-a672fa7446c012019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14789-700PROCHLORPERAZINE EDISYLATE INJECTION [NEXUS PHARMACEUTICALS LLC]12Legacy NDC20250326_ed9e300a-c577-4c78-a806-3a586ab5f1c7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
14789-700-021478907000210 VIAL, SINGLE-DOSE in 1 CARTON (14789-700-02) > 2 mL in 1 VIAL, SINGLE-DOSE (14789-700-07) 2019-02-250000-00-00NoNoCurrent