FDA.reportPublic FDA data

NDC 68083-435-01 - Prochlorperazine Edisylate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68083-435
Requested NDC
68083-435-01
Package NDCs from labels
68083-435-01, 68083-435-25, 68083-435-10
Manufacturer
Gland Pharma Limited
Effective date
2024-12-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Prochlorperazine Edisylate - Gland Pharma LimitedGland Pharma Limited2024-12-12Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-435-01Prochlorperazine Edisylate2 mL in 1 VIALINJECTION26
68083-435-10Prochlorperazine Edisylate10 in 1 CARTONINJECTION106
68083-435-25Prochlorperazine Edisylate25 in 1 CARTONINJECTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-435PROCHLORPERAZINE EDISYLATE INJECTION [GLAND PHARMA LIMITED]6Current NDC, Legacy NDC, 3 package rows20241215_a0fd3d58-7470-4d0f-9e6c-84e92c02a97f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 13 · 247 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relieving Cream LidocaineBENZYL ALCOHOL, LIDOCAINE HCITrifecta Pharmaceuticals USA LLC039a2036-54b2-cf28-e063-6294a90a8ce62024-12-31WarningsExact identifier
unii: LKG8494WBH
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEFOSUN PHARMA USA INCf793cdb3-9fd8-79e1-e053-6394a90ae08b2024-12-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214107
rxcui: 2102949
unii: PG20W5VQZS
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEGland Pharma Limiteda0fd3d58-7470-4d0f-9e6c-84e92c02a97f2024-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214107
ndc (package): 68083-435-10
ndc (package): 68083-436-01
ndc (package): 68083-435-25
ndc (package): 68083-435-01
ndc (product): 68083-436
ndc (product): 68083-435
ndc11 (package): 68083043501
rxcui: 2102949
spl id: 868ffb82-fd9b-4157-9e2c-1b76191ac1aa
spl set id: a0fd3d58-7470-4d0f-9e6c-84e92c02a97f
unii: PG20W5VQZS
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEAvenacy Inc.fd07a1a3-c0df-4926-9964-07348e45a5fd2024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0338b221-db43-45c9-a829-d970fe6643ab2024-12-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
unii: LKG8494WBH
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
unii: LKG8494WBH
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECosette Pharmaceuticals, Inc.4687b9f5-2d67-4fe0-af4d-2415a42b52922024-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS
Orajel Toothache RinseBENZYL ALCOHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.41709710-5392-3119-e054-00144ff88e882024-11-27WarningsExact identifier
unii: LKG8494WBH
PhysiciansCare Ophthalmic Solution Eyewash Purified Water, 98.3%PURIFIED WATER 98.3%Acme United Corporation9248ee71-2d47-620d-e053-2995a90af5c82024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEAmneal Pharmaceuticals LLCe913d678-7a5d-4e74-9e9c-1b9a3affd2652024-11-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
unii: LKG8494WBH
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEEugia US LLC24358d03-d06d-4946-8ebd-a62bc15d33c02024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS
prochlorperazine edisylatePROCHLORPERAZINE EDISYLATEMylan Institutional LLC185c1647-06ea-401e-ad1d-8727d77eb8272024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PG20W5VQZS
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.