FDA.reportPublic FDA data

NORTRIPTYLINE HYDROCHLORIDE - Food and Drug Administration

Manufacturer
Food and Drug Administration
Effective date
2021-07-29
Label type
Indexing - Product Concept
Version
2
Source
full-release
Hydrated at
2026-06-05 00:19:49

Label at a glance#

ProductNORTRIPTYLINE HYDROCHLORIDE
Active ingredientNORTRIPTYLINE HYDROCHLORIDE

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
NORTRIPTYLINE HYDROCHLORIDE00FN6IH15DACTIM
NORTRIPTYLINE HYDROCHLORIDE00FN6IH15DACTIM
NORTRIPTYLINE HYDROCHLORIDE00FN6IH15DACTIM
NORTRIPTYLINE HYDROCHLORIDE00FN6IH15DACTIM

Source Document#

Source XML

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 3 · 54 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.4852a754-2fc1-4c10-a414-dc8a1dfd66a22026-09-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.c7cce83f-9508-49de-a442-246ad18ddeda2026-08-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepackcb4d1a69-60ae-4fdc-8af8-059959cf72652026-08-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.f684e9c8-eca7-4e27-872d-c0adea19de9a2026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c282026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEProficient Rx LP1e32f284-a5b2-4ebf-9d9e-0e9a40b46ade2026-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy3c57301f-5128-295e-e063-6394a90ad99e2026-06-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.dd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa2026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.522d0cd8-d84d-4961-a525-4527fce44c3c2026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.27e96d6c-b311-45d2-b879-65c6a4efcfba2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY21770082-7a99-520d-e063-6394a90ab9cb2026-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsa2cf7783-7019-49ea-ab55-796674d945462026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEBryant Ranch Prepack8eef261f-5c78-a88f-37c4-46e6b0e0f0ee2026-03-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDECoupler LLC4c21abdb-f3e9-9037-e063-6294a90af4b42026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3fcabf90-357a-4a06-b680-9572dc28bcfe2026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
NORTRIPTYLINE HYDROCHLORIDENORTRIPTYLINE HYDROCHLORIDEDirect Rx017f7717-e160-4142-9a5a-1a2bd97767072026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: NORTRIPTYLINE HYDROCHLORIDE
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAdvagen Pharma Ltdbef9e24d-e730-4801-ab25-75e7d6bde2252026-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLCdae3314f-3128-787f-e053-2995a90aff192026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLC09a54dbd-6bde-3083-e063-6394a90a52972025-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutions686d15d0-6434-42ec-8c78-f45d617d294c2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Nortriptyline Hydrochloride
generic name: NORTRIPTYLINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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