FDA.reportPublic FDA data

NDC 62991-2004-1

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
62991-2004
Requested NDC
62991-2004-1
Package NDCs from labels
62991-2004-1
Manufacturer
National Council for Prescription Drug Programs
Effective date
2013-02-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-19Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62991-2004-1GM - Gram62991-20045910b948-2340-407b-a4d8-e15f05e9919612013-02-19
62991-2004-2GM - Gram62991-2004c5276642-aae1-47d9-ab35-b2f8249fd8d712013-02-19
62991-2004-3GM - Gram62991-2004b8e5cc14-7c08-4921-a7c6-ffc2b61e646c12013-02-19
62991-2004-4GM - Gram62991-2004b2d16faa-ee77-495e-a5fc-65b16f13e58012013-03-03

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 4 of 6 · 120 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.1523a2b4-f9d6-4d3c-a370-df579ed369112025-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.d7bfeb47-2482-4217-b522-df44444991332025-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions9110367c-4104-4836-8af3-649f86b0b3ea2025-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEMajor Pharmaceuticals29ec1221-04d8-4b21-822e-2779fcaae62c2025-06-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions85574987-8d31-4bd0-b829-bb154ef212f52025-06-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthstar Rx LLC.8ed28f42-e41a-45ca-a86f-849ebeb6ab802025-06-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.9c6e0e05-b579-4fae-b768-e1a664c39bb82025-06-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESandoz Inc705a2bae-031d-4218-82fe-4346542c0baa2025-05-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY35a6e911-507a-ef0d-e063-6294a90a07e12025-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY35a7ce7d-4a29-e3f0-e063-6294a90ad66f2025-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack2bda8478-f5ab-440a-a8a3-61ebc57213692025-05-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack86bad1a5-48c3-4a8a-970f-8fdbda078b4e2025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HCLAMITRIPTYLINE HCLDirect_Rx3504be24-1e75-5e68-e063-6294a90a270a2025-05-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HCL
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDERising Pharma Holdings, Inc.a219a68e-7ce5-4e9d-a0de-ec76960040f62025-04-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.73669354-babc-4687-a4fe-ad0fc1f863ba2025-03-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsbbbd535d-0bce-469e-917f-70a6ebd2f0072025-02-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions69c7a0bd-93d0-40fe-a6d3-f41986b802b42025-02-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HCLAMITRIPTYLINE HCLDirect_Rxf420498a-bfcc-4549-e053-2995a90a7b092025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HCL
Amitriptyline HCLAMITRIPTYLINE HCLDirect_Rxf6dc463b-3601-48c0-e053-6294a90a2d772025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HCL
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAvPAKf5c5f3b6-e92b-1120-e053-2995a90ae8fa2025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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