FDA.reportPublic FDA data

NDC 70518-4048-01 - Amitriptyline Hydrochloride

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
70518-4048
Requested NDC
70518-4048-01
Package NDCs from labels
70518-4048-0, 70518-4048-1, 70518-4048-2, 70518-4048-3, 70518-4048-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amitriptyline Hydrochloride Tablets, USP Rx onlyREMEDYREPACK INC.2026-08-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4048-0Amitriptyline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET904
70518-4048-1Amitriptyline Hydrochloride30 in 1 BLISTER PACKTABLET304
70518-4048-2Amitriptyline Hydrochloride30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4048AMITRIPTYLINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]2Current NDC, 3 package rows20240907_5dc3c2d7-60a2-4754-be33-1f9401c925a4.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 55 of 169 · 3,370 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flawless FinishTITANIUM DIOXIDE, ZINC OXIDEENSO SKINCARE & WELLNESS LLC3b8df7ce-e5ce-aaf8-e063-6394a90afdae2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Lip BalmTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369d63a9-b9a9-9530-e063-6394a90ac8ef2025-12-17Exact identifier
unii: 15FIX9V2JP
Matte TintTITANIUM DIOXIDE, ZINC OXIDEPATRICIA SOLIS MAKEUP ARTIST, LLC369ced69-59b4-0f3c-e063-6294a90a582f2025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b0ac77-13d8-4259-e063-6394a90a893b2025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Non-TintedTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b000e3-2516-932c-e063-6294a90a0e412025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDELOTUS SKINCARE AND MAKE-UP STUDIO36b1a6c8-b4ff-089a-e063-6394a90a24692025-12-17Exact identifier
unii: 15FIX9V2JP
Covergirl Clean Fresh Tinted Lip Balm Glowing Protection SPF 15 Mineral Sunscreen - All shadesZINC OXIDE AND TITANIUM DIOXIDENoxell2cdbeb73-b805-f144-e063-6294a90a088d2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUMEnergetix Corporation9b532a31-530a-44f9-843f-f395a3e460b82025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Alcohol Prep PadsISOPROPYL ALCOHOLFamily Dollar Stores, Inc.15af30ec-f77d-2f5c-e063-6394a90a05802025-12-17WarningsExact identifier
unii: ND2M416302
LEG CRAMPS PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURWalgreen Companyd8c7ec58-5453-0e58-e053-2995a90abff12025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Pan-Zyme-SPANCREAS BALANCEVitality Works, Inc.4f6e18ca-719c-445e-9dad-fc40ad9e1aeb2025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
RPT-SysEMOTIONAL REBALANCEVitality Works, Inc.0e8768fe-c2ba-41e9-93ac-c142fae6e8792025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Signature Select Isopropyl Alcohol Wipes (40 count)ISOPROPYL ALCOHOLBetter Living Brands LLCc9efcad4-f85c-4b10-9984-55549a4ff0262025-12-17WarningsExact identifier
unii: ND2M416302
Mattifying Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColorescienceb27d7df0-3c84-4cc5-9ef3-07105311fed92025-12-17WarningsExact identifier
unii: 15FIX9V2JP
DigestivEaseARSENICUM ALB, CALC SULPH, CARBO AN, CARBO VEG, CINCHONA, HYDRASTIS, NOX VOM, ORNITHOGALUM, PYROGENIUM, SILICEAEight and Company L.L.C70840ff7-75c0-44a0-9eb8-b36f13518af22025-12-17WarningsExact identifier
unii: ETJ7Z6XBU4
Cetaphil Redness Relieving Daily Facial Moisturizer with sunscreen SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.45d101be-2b88-4759-9ccc-556f5ec0553d2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions085baad2-d1c7-499e-b553-7477befd04d02025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
unii: 26LUD4JO9K
Brightening Primer SPF 20TITANIUM DIOXIDE AND ZINC OXIDEColoresciencea42d6761-47cd-4c9b-9656-64e37e0656392025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsace6748d-735c-4e6e-b327-a20101fd23d42025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
unii: 26LUD4JO9K
Isopropyl AlcoholISOPROPYL ALCOHOLCVS PHARMACY, INC4f628fbd-e213-43ac-9699-d678331f37652025-12-17WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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