FDA.reportPublic FDA data

NDC 17856-4070-2 - Phenytoin

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
17856-4070
Requested NDC
17856-4070-2
Package NDCs from labels
17856-4070-2, 17856-4070-1
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-05-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenytoin - ATLANTIC BIOLOGICALS CORP.ATLANTIC BIOLOGICALS CORP.2025-05-28HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-4070-12024-05-09C16284748780-11030e365-660b-111a-e063-dadaa90a10e2PHENYTOIN ORAL SUSPENSION These highlights do not include all the information needed to use PHENYTOIN ORAL SUSPENSION safely and effectively. See full prescribing information for PHENYTOIN ORAL SUSPENSION. PHENYTOIN oral suspension Initial U.S. Approval: 1953
17856-4070-12024-01-30C16284748780-11030e365-660b-111a-e063-dadaa90a10e2PHENYTOIN ORAL SUSPENSION These highlights do not include all the information needed to use PHENYTOIN ORAL SUSPENSION safely and effectively. See full prescribing information for PHENYTOIN ORAL SUSPENSION. PHENYTOIN oral suspension Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-4070-1Phenytoin72 in 1 BOX, UNIT-DOSESUSPENSION725
17856-4070-2Phenytoin4 mL in 1 CUP, UNIT-DOSESUSPENSION45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-4070PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]4Current NDC, Legacy NDC, 2 package rows20240510_09daf485-3355-44cb-92af-072dd281e129.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-4070-1ML - Milliliter17856-407031c2fda1-c530-4268-a9b7-f67ad79488e112025-06-13

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 20 of 22 · 426 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticoagulant Citrate Phosphate Dextrose (CPD) Blood-Pack Units in PL 146 PlasticANTICOAGULANT CITRATE PHOSPHATE DEXTROSE (CPD)Fenwal, Inc.4a08a9ec-46a5-4fcf-80ee-5c33f1a8b7462022-11-01Exact identifier
unii: XF417D3PSL
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: K679OBS311
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: K679OBS311
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: K679OBS311
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
unii: K679OBS311
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: K679OBS311
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
unii: K679OBS311
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
Bio Co-Enzyme PhaseBETA VULGARIS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.e8f6e2ec-ae2e-4bee-b9d3-5f3a2e3daf652022-05-09WarningsExact identifier
unii: XF417D3PSL
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: XF417D3PSL
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: XF417D3PSL
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
TH-101CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROBTemple Health Nutrition, LLCd54bb860-560c-4f8f-9aea-a0b7774cc92b2021-12-29WarningsExact identifier
unii: C151H8M554
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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