FDA.reportPublic FDA data

NDC 0143-9245-01 - Dacarbazine

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
0143-9245
Requested NDC
0143-9245-01
Package NDCs from labels
0143-9245-01, 0143-9245-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2025-09-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dacarbazine for Injection, USPHikma Pharmaceuticals USA Inc.2025-09-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9245-01Dacarbazine1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,16
0143-9245-10Dacarbazine10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9245DACARBAZINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20240504_0d81315c-7021-4091-b703-ad135390c936.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9245-01EA - Each0143-92454c16d649-63a8-4d8a-8bf0-01ef7f5255a812020-08-06
0143-9245-10EA - Each0143-9245bb103c9a-9efe-47d2-b075-cacbafa8fc2412020-08-06

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 2 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HZ-ChordBAPTISIA TINCTORIA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HYDROCOTYLE ASIATICA, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MEZEREUM, MORBILLINUM, NUX VOMICA, PALOONDO, PHYTOLACCA DECANDRA, SEPIA, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Energetix Corporation9685aec5-a65d-40fe-b5d7-2f13a69733bc2025-12-17WarningsExact identifier
unii: XF417D3PSL
Category VIMMUNE SYSTEM BOOSTERVitality Works, Inc,0d3dd923-336c-4ccd-a344-ec49b2e80d102025-12-17WarningsExact identifier
unii: XF417D3PSL
FCS HPEPINEPHRINE,GLUTAMICACID,MUCUNAPRURIENSSEED,NIACINAMIDE,SEROTONIN,UBIDECARENONE,CORTICOTROPIN,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATECRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inc.ba8fed68-f27f-4651-adec-0994a53758872025-12-10WarningsExact identifier
unii: XF417D3PSL
FCS CPCORTICOTROPIN,GLUTAMICACID,MUCUNAPURIENSSEED,SEROTONIN,EPINEPHRINE,NIACINAMIDE,UBIDECARENONE,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,UNSPECIFIED,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATE,CRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inccb69e9d6-62a6-4af0-8d2d-1e68b0830a202025-12-10WarningsExact identifier
unii: XF417D3PSL
Alka-Seltzer Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRINBayer HealthCare LLC.49b73bd5-6465-05eb-e054-00144ff88e882025-12-04WarningsExact identifier
unii: XF417D3PSL
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
unii: XF417D3PSL
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.ab19b011-0a51-4f04-9881-d9fc7cae95ae2025-11-25Exact identifier
unii: XF417D3PSL
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATER J General Corporationdbb0d067-71f0-45e4-bc98-548cf4a90b3a2025-11-17WarningsExact identifier
unii: XF417D3PSL
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
unii: XF417D3PSL
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Mitochondria PROARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: XF417D3PSL
Kidnex IVGINKGO BILOBA, ALPHA-KETOGLUTARICUM ACIDUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MALICUM ACIDUM, PYRUVIC ACID, SUCCINICUM ACIDUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, GERMANIUM SESQUIOXIDE, MERCURIUS VIVUS, NUX VOMICA, KIDNEY (SUIS), LYMPH NODE (SUIS), NAPHTHOCHINONUM, NATRUM OXALACETICUM, PHOSPHORUS, URINARY BLADDER (SUIS), ACONITICUM ACIDUM, CIS-Energique, Inc.121eb51a-befe-47ea-85c6-d77e8c7e58642025-10-06WarningsExact identifier
unii: XF417D3PSL
DacarbazineDACARBAZINEHikma Pharmaceuticals USA Inc.0d81315c-7021-4091-b703-ad135390c9362025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075812
ndc (package): 0143-9245-01
ndc (package): 0143-9245-10
ndc (product): 0143-9245
ndc11 (package): 00143924501
rxcui: 1731338
spl id: bbbf119e-26f4-46c1-ba80-de927e51c566
spl set id: 0d81315c-7021-4091-b703-ad135390c936
unii: 7GR28W0FJI
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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