FDA.reportPublic FDA data

NDC 80425-0287-01 - 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
80425-0287
Requested NDC
80425-0287-01
Package NDCs from labels
80425-0287-1, 80425-0287-2, 80425-0287-3, 80425-0287-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amitriptyline Hydrochloride - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0287-1Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
80425-0287-2Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
80425-0287-3Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0287AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 3 package rows20250102_f78102eb-cbeb-801a-e053-6294a90ab880.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0287-1EA - Each80425-0287205c2865-d64d-441b-82ed-cc6d1dc930ef12023-06-06
80425-0287-2EA - Each80425-028793234ea3-de3b-4dfc-9a45-caccf14626fb12023-06-06
80425-0287-3EA - Each80425-0287c3e7e4a4-5849-41a7-a2a5-87bdaee2d75012023-06-06

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 5 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HCLAMITRIPTYLINE HCLDirect_Rxf6dc463b-3601-48c0-e053-6294a90a2d772025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214548
rxcui: 856853
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAvPAKf5c5f3b6-e92b-1120-e053-2995a90ae8fa2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214548
rxcui: 856762
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAvPAKfd771b4b-c7ae-8e69-e053-6294a90a21202025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214548
rxcui: 856834
rxcui: 856853
rxcui: 856783
rxcui: 856845
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC082b620f-8085-d205-e063-6294a90ac6de2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214548
rxcui: 856845
unii: 26LUD4JO9K
Amitriptyline HCLAMITRIPTYLINE HCLAdvanced Rx Pharmacy of Tennessee, LLCca66c2fc-6724-f4cd-e053-2995a90a42cf2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856783
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf98d25a7-6b47-38a9-e053-6394a90a541d2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214548
rxcui: 856834
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf78102eb-cbeb-801a-e053-6294a90ab8802024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214548
ndc (package): 80425-0287-2
ndc (package): 80425-0287-1
ndc (package): 80425-0287-3
ndc (product): 80425-0287
ndc11 (package): 80425028701
rxcui: 856762
spl id: 2a9b9724-0257-e829-e063-6394a90a1c07
spl set id: f78102eb-cbeb-801a-e053-6294a90ab880
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC19b0c015-c07f-63b7-e063-6394a90a60602024-11-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
rxcui: 856762
unii: 26LUD4JO9K
Amitriptyline HCLAMITRIPTYLINE HCLDirect_Rx23ab2afe-06c1-fa61-e063-6394a90abcf82024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856773
unii: 26LUD4JO9K
Amitriptyline HCLAMITRIPTYLINE HCLDirect_rx227affe9-36ee-2423-e063-6394a90a58f62024-09-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856762
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack3d9292dc-49a0-46f4-9980-3e8d57121d432024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856845
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack8c9f605f-ac13-442f-af4d-ea11102474de2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214548
rxcui: 856783
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC20aff9dc-98a7-6061-e063-6394a90a2aab2024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856845
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackac1a7640-58d7-494d-94c8-27911470bf592024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214548
rxcui: 856845
unii: 26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack76d3f4fd-4603-4cfc-94ab-2e62c0bdae752024-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
rxcui: 856853
rxcui: 856783
rxcui: 856845
rxcui: 856773
rxcui: 856762
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepacka726f82c-1018-44ee-ab1f-f5d34e6b388e2024-08-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack6a176cd7-7c13-440e-b6bb-dc2fab3f2a122024-08-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA214548
rxcui: 856834
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.1e78e304-00e8-7cb3-e063-6294a90a87ad2024-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
unii: 26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.58ff9a82-5de6-a1b0-e053-2991aa0a84ba2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856783
unii: 26LUD4JO9K
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.5a5a4040-5395-54ac-e053-2991aa0aa4ab2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856783
unii: 26LUD4JO9K

Reported adverse events (FAERS/openFDA)#

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