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 2 of 172 · 3,424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WalmartISOPROPYL ALCOHOLWalmart, Inc.2eff98ba-5736-b07e-e063-6394a90aeea92026-09-04WarningsExact identifier
unii: ND2M416302
Walgreen AlcoholISOPROPYL ALCOHOLWalgreens Companydeeae1ea-3d81-4260-95be-c4f328e3fdef2026-09-04WarningsExact identifier
unii: ND2M416302
Dollar GeneralISOPROPYL ALCOHOLDollar General Corporation00b2ef34-42d9-523c-e063-6294a90a753d2026-09-03WarningsExact identifier
unii: ND2M416302
Signature Select Alcohol Prep PadsISOPROPYL ALCOHOLBetter Living Brands LLC31ce72e3-03a3-1608-e063-6394a90ad8502026-09-03WarningsExact identifier
unii: ND2M416302
SurviveX Sting ReliefSTING RELIEF WIPEChangzhou Maokang Medical Products Co., Ltd.5a83b1f1-c8dc-cf07-e063-6394a90a20ca2026-09-03WarningsExact identifier
unii: ND2M416302
SurviveX Antiseptic WipesBZK ANTISEPTIC CLEANING WIPEChangzhou Maokang Medical Products Co., Ltd.5a82d9fb-dff8-1c89-e063-6394a90a32c92026-09-03WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLRite Aid Corporation5104f9ab-0b28-449f-a55a-5438713a24df2026-09-02WarningsExact identifier
unii: ND2M416302
AlcoholISOPROPYL ALCOHOLThe Kroger Company6551187f-5cde-4149-931f-b057bd7607502026-09-02WarningsExact identifier
unii: ND2M416302
Harris TeeterISOPROPYL ALCOHOLHarris Teeter, LLCd2bb20bd-ec83-8d80-e053-2a95a90a2bba2026-09-02WarningsExact identifier
unii: ND2M416302
School HealthISOPROPYL ALCOHOLSchool Health Corporationdb5d0b22-f2d7-23e5-e053-2a95a90aeb512026-09-02WarningsExact identifier
unii: ND2M416302
Alcohol Prep PadsISOPROPYL ALCOHOLTopco Associates2642298f-607e-fdca-e063-6394a90a69d92026-09-02WarningsExact identifier
unii: ND2M416302
Medline Alcohol Swabstick TriplesISOPROPYL ALCOHOLMedline Industries, LPe7759368-97c5-4b10-9bca-c197aeb62e462026-09-01WarningsExact identifier
unii: ND2M416302
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
70% Isopropyl AlcoholISOPROPYL ALCOHOLUpLift Brands, LLC8ae12375-3a95-475c-9600-17c51a9103f72026-08-31Warnings, Adverse reactionsExact identifier
unii: ND2M416302
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.bb02d7b8-8f1a-4cc4-b763-223e6894f02c2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217411
rxcui: 856762
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.4132f91e-6f24-476a-9028-bab86ad0598e2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217411
rxcui: 856834
unii: 26LUD4JO9K
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.5dc3c2d7-60a2-4754-be33-1f9401c925a42026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217411
ndc (package): 70518-4048-2
ndc (package): 70518-4048-3
ndc (package): 70518-4048-1
ndc (package): 70518-4048-0
ndc (product): 70518-4048
ndc11 (package): 70518404801
rxcui: 856845
spl id: 59f25612-cb35-5182-e063-6294a90ac62f
spl set id: 5dc3c2d7-60a2-4754-be33-1f9401c925a4
unii: 26LUD4JO9K

Reported adverse events (FAERS/openFDA)#

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