FDA.reportPublic FDA data

NDC 43485-101-01 - Spritam

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
43485-101
Requested NDC
43485-101-01
Package NDCs from labels
43485-101-01, 43485-101-60, 43485-101-03
Manufacturer
Aprecia Pharmaceuticals, LLC
Effective date
2025-10-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Spritam - Aprecia Pharmaceuticals, LLCAprecia Pharmaceuticals, LLC2025-10-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43485-101-01Spritam1 in 1 BLISTER PACKTABLET, FOR SUSPENSION129
43485-101-03Spritam6 in 1 CARTONTABLET, FOR SUSPENSION629
43485-101-60Spritam60 in 1 CARTONTABLET, FOR SUSPENSION6029

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43485-101SPRITAM (LEVETIRACETAM) TABLET, FOR SUSPENSION [APRECIA PHARMACEUTICALS, LLC]26Current NDC, Legacy NDC, 3 package rows20241222_be651c31-383f-11e4-916c-0800200c9a66.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43485-101-01EA - Each43485-101896fe2d2-0b5d-4f2e-94f5-b1c1c5505b3612016-03-04
43485-101-60EA - Each43485-101c7fa9dc8-dccc-453a-976c-ea00b52ea90112016-03-04

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 30 of 57 · 1,135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1b4e96-c96f-6424-e053-2991aa0aef302025-07-24WarningsExact identifier
unii: ETJ7Z6XBU4
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1a9ef9-9a54-5f94-e053-2a91aa0ab4772025-07-24WarningsExact identifier
unii: ETJ7Z6XBU4
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
unii: PDC6A3C0OX
Cold Sore Fast-Acting Pain ReliefGLYCERIN AND LIDOCAINEBlistex Inc.c7511322-dd6c-441c-bf7d-ad4f0c14956a2025-07-22WarningsExact identifier
unii: PDC6A3C0OX
Cureforte Breath ResetMOUTH SPRAYSTEEL CITY HEALTH PRIVATE LIMITED38ddf1a7-29ab-cb8d-e063-6294a90ad34c2025-07-21WarningsExact identifier
unii: PDC6A3C0OX
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
unii: PDC6A3C0OX
SilkTearsGLYCERIN OPHTHALMIC SOLUTIONSilkTears3866e2c1-051b-0b01-e063-6394a90af5cf2025-07-16WarningsExact identifier
unii: PDC6A3C0OX
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: ETJ7Z6XBU4
DENTAL-CHORDACETICUM ACIDUM, AMMONIUM MURIATICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARBOLICUM ACIDUM, CITRUS LIMONUM, CUPRUM METALLICUM, FERRUM METALLICUM, GLYCYRRHIZA GLABRA, LAPPA MAJOR, MEDULLA OSSIS SUIS, MERCURIUS SOLUBILIS, MYRRHA, NATRUM FLUORATUM, PALLADIUM METALLICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA, STANNUM METALLICUM, STAPHYSAGRIA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, X-RAY, ZINCUM OXYDATUMEnergetix Corporation6c9ba926-7c35-49fd-94d8-988ca0bb772c2025-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
unii: PDC6A3C0OX
EndocrinpathALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corporation70f84941-b8a1-48f4-9c05-554e554f00492025-07-11WarningsExact identifier
unii: ETJ7Z6XBU4
LevetiracetamLEVETIRACETAMPreferred Pharmaceuticals, Inc.e31c6830-4647-4481-b4f1-494a52c48b1b2025-07-11Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
unii: PDC6A3C0OX
Schuessler Tissue Salts Silica 6X Cleanser and Conditioner 12SILICEAMartin & Pleasance Pty Ltd39620db9-5099-47f0-93ad-c00e6625c4622025-07-07WarningsExact identifier
unii: ETJ7Z6XBU4
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
unii: PDC6A3C0OX
LevetiracetamLEVETIRACETAMPrasco Laboratoriesdd175fa3-1d7a-4542-affd-988ac5bba1db2025-07-01Warnings, Adverse reactionsExact identifier
application number: NDA207958
rxcui: 1736048
rxcui: 1736045
unii: 44YRR34555
SEFUDUN FUNGAL NAIL PATCHESGLYCERINShenzhen Shandian Jingling Technology Co., Ltd.38db97d6-27c8-da99-e063-6294a90aac662025-07-01WarningsExact identifier
unii: PDC6A3C0OX
KeppraLEVETIRACETAMUCB, Inc.c6d5784d-abf9-45fe-ac5a-d5c53bd50f7e2025-06-30Warnings, Adverse reactionsExact identifier
unii: 44YRR34555
Arnica Calendula WoundARNICA CALENDULA WOUNDUriel Pharmacy, Inc38cfd292-4dbd-2caf-e063-6394a90a05272025-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
BacAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA CHAMOMILLA FLOWERING TOP OIL, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS WHOLE, TOXICODENDRON PUBESCENS LEAF, AND SILICON DIOXIDEZorex7ae38e0c-8e74-4fd5-8605-45e424a84d012025-06-30WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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