FDA.reportPublic FDA data

NDC 70518-4366-00 - 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
70518-4366
Requested NDC
70518-4366-00
Package NDCs from labels
70518-4366-0, 70518-4366-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amitriptyline Hydrochloride Tablets, USPREMEDYREPACK INC.2026-09-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4366-0Amitriptyline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, COATED903

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 1 of 112 · 2,236 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.61b29703-cfc2-45c7-ae24-7bf3b77e85872026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212654
ndc (package): 70518-4366-0
ndc (product): 70518-4366
ndc11 (package): 70518436600
rxcui: 856762
spl id: 5b0c4d85-612a-ab88-e063-6394a90a3ffa
spl set id: 61b29703-cfc2-45c7-ae24-7bf3b77e8587
unii: 26LUD4JO9K
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.e0aa02a9-3e2d-44c5-a6b9-843c801022492026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856853
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.4e520c63-1cf6-40f6-a51c-3f9b0e1813422026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
rxcui: 856853
rxcui: 856783
rxcui: 856845
rxcui: 856773
rxcui: 856762
unii: 26LUD4JO9K
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.c072c1b3-ed8a-4f1e-ba6c-580a2b2c8f582026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212654
rxcui: 856834
unii: 26LUD4JO9K
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
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
rxcui: 856762
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.4132f91e-6f24-476a-9028-bab86ad0598e2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
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
rxcui: 856845
unii: 26LUD4JO9K
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC598f6ffb-45c3-3cfc-e063-6294a90a56d12026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC598f900c-552b-5653-e063-6294a90aff532026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856762
unii: 26LUD4JO9K

Reported adverse events (FAERS/openFDA)#

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