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 6 of 6 · 120 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackc707a873-6b67-478f-aa3c-d206a59cbe6d2024-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack4ce78bf6-61ec-435f-9af5-c86df440892a2024-05-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC18ff2901-08fd-37f0-e063-6394a90a1ad22024-05-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEProficient Rx LPce665435-b2f1-4fcd-ae20-4f372f3760952024-05-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAsclemed USA, Inc.776d2c2c-d897-4da1-a99a-b4324e1f864f2024-03-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEProficient Rx LP61133866-b01c-4278-93fb-4564c1b56e542024-03-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack541ba74a-babb-4731-a5ef-fe7c18992c0b2024-01-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackdcdeb999-412e-475f-a21d-2e0ac42d136e2024-01-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions00d11130-c9ae-4258-9746-9763bc5deb842023-12-22Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions5e8c8c5f-4964-4642-ad4b-69a75b2c8a022023-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsd22879c5-925a-42e0-9d48-55a4221929832023-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEProficient Rx LP6dc9d113-1156-43ec-a7eb-253c2ff6bcfa2023-12-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC25832051-837b-4682-8548-5ab9a1b7cdac2023-11-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4e0f3b15-3621-48a1-9f2b-b0a3739203602023-09-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEProficient Rx LPe42225f5-44bd-451e-98a1-aa38774577332023-08-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions1a622039-0a79-407c-8f15-2ea0c58441362023-04-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC8746c047-51b9-4040-aeec-cd1f5b6eb3d42023-03-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions9440dd10-2f0d-42a7-a037-3ab8729708f62023-01-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECentaur Pharmaceuticals Private Limited3d113e43-c694-427f-8b77-66be36a823742022-09-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEProficient Rx LPdf5aee40-ffa9-4cf3-ab5f-30253f43092b2022-05-02Boxed 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.