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 5 of 6 · 120 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAvPAKfd771b4b-c7ae-8e69-e053-6294a90a21202025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC082b620f-8085-d205-e063-6294a90ac6de2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HCLAMITRIPTYLINE HCLAdvanced Rx Pharmacy of Tennessee, LLCca66c2fc-6724-f4cd-e053-2995a90a42cf2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HCL
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf98d25a7-6b47-38a9-e053-6394a90a541d2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf78102eb-cbeb-801a-e053-6294a90ab8802024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC19b0c015-c07f-63b7-e063-6394a90a60602024-11-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HCLAMITRIPTYLINE HCLDirect_Rx23ab2afe-06c1-fa61-e063-6394a90abcf82024-10-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HCL
Amitriptyline HCLAMITRIPTYLINE HCLDirect_rx227affe9-36ee-2423-e063-6394a90a58f62024-09-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HCL
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack3d9292dc-49a0-46f4-9980-3e8d57121d432024-09-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack8c9f605f-ac13-442f-af4d-ea11102474de2024-08-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC20aff9dc-98a7-6061-e063-6394a90a2aab2024-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackac1a7640-58d7-494d-94c8-27911470bf592024-08-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack76d3f4fd-4603-4cfc-94ab-2e62c0bdae752024-08-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepacka726f82c-1018-44ee-ab1f-f5d34e6b388e2024-08-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack6a176cd7-7c13-440e-b6bb-dc2fab3f2a122024-08-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.1e78e304-00e8-7cb3-e063-6294a90a87ad2024-07-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.58ff9a82-5de6-a1b0-e053-2991aa0a84ba2024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.5a5a4040-5395-54ac-e053-2991aa0aa4ab2024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsb793f1f8-c1f9-46f0-8156-1a4957db3a1f2024-06-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMITRIPTYLINE HYDROCHLORIDE
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions0067b698-ee1d-4524-b1cc-af1028d137362024-06-12Boxed 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.