FDA.reportPublic FDA data

NDC 0641-6135-01 - 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
0641-6135
Requested NDC
0641-6135-01
Package NDCs from labels
0641-6135-01, 0641-6135-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2025-01-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Prochlorperazine Edisylate Injection, USPHikma Pharmaceuticals USA Inc.2025-01-29HUMAN PRESCRIPTION DRUG LABEL
PROCHLORPERAZINE EDISYLATE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2024-01-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6135-01Prochlorperazine Edisylate2 mL in 1 VIALINJECTION27
0641-6135-25Prochlorperazine Edisylate25 in 1 CARTONINJECTION257

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6135PROCHLORPERAZINE EDISYLATE INJECTION [HIKMA PHARMACEUTICALS USA INC.]7Current NDC, Legacy NDC, 2 package rows20250130_baf59816-7577-4652-b065-fb6de9e54569.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6135-01ML - Milliliter0641-6135c57f245a-6b8b-4af3-8c94-37178969094f12016-11-08
0641-6135-25ML - Milliliter0641-613564870d1d-901a-4468-98a4-a95dc6523b8e12016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROCHLORPERAZINE EDISYLATEACTIVE INGREDIENTPG20W5VQZSPROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]2
PROCHLORPERAZINEACTIVE MOIETYYHP6YLT61TPROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNPROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]2
SODIUM TARTRATE DIHYDRATEINACTIVE INGREDIENTDIA7C37AOWPROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]2
WATERINACTIVE INGREDIENT059QF0KO0RPROCHLORPERAZINE EDISYLATE INJECTION [WEST-WARD PHARMACEUTICALS CORP.]2

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 6 of 13 · 247 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0dc48e66-6081-421b-952b-4867c9c4c7942025-03-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2102949
unii: PG20W5VQZS
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
MB CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLC2efeb281-b84b-4750-e063-6394a90a27ee2025-02-25Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATEHikma Pharmaceuticals USA Inc.baf59816-7577-4652-b065-fb6de9e545692025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA089903
ndc (package): 0641-6135-01
ndc (package): 0641-6135-25
ndc (product): 0641-6135
ndc11 (package): 00641613501
rxcui: 314192
spl id: 6ffbbb71-5711-43b7-beb5-5ccfb6128cb5
spl set id: baf59816-7577-4652-b065-fb6de9e54569
unii: PG20W5VQZS
Prochlorperazine EdisylatePROCHLORPERAZINE EDISYLATECivica, Inc.e3e0c6c5-6b92-40e0-a926-29c64846be932025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA089903
rxcui: 314192
unii: PG20W5VQZS
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co. LLC, DBA HealthFirst74ed2a6f-824c-a1ff-e053-2a91aa0a57c02025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst77bd3c0f-f4ab-7cfa-e053-2a91aa0a1b832025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
URIMAR-T CAPSMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEAllegis Pharmaceuticals, LLCcf7c3d65-11d2-49cd-b207-8ccc6a221fe02025-01-08Warnings, Adverse reactionsExact identifier
unii: 593YOG76RN
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: LKG8494WBH

Reported adverse events (FAERS/openFDA)#

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