FDA.reportPublic FDA data

amitriptyline HCl 25 MG Oral Tablet

RxCUI
856834
RxNorm name
amitriptyline HCl 25 MG Oral Tablet
Display name
amitriptyline HCl 25 MG Oral Tablet
Full name
amitriptyline HCl 25 MG Oral Tablet
Term type
PSN
Status
DailyMed mapping
Updated
2026-06-04 23:39:02

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.4e520c63-1cf6-40f6-a51c-3f9b0e1813422026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.c072c1b3-ed8a-4f1e-ba6c-580a2b2c8f582026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.4132f91e-6f24-476a-9028-bab86ad0598e2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC598f6ffb-45c3-3cfc-e063-6294a90a56d12026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionse0d5b1f6-c1f2-4d5b-a1c3-aebe77843df22026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.c66e9088-4f34-4b97-971e-5272b45cfc972026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy35aa7ab3-321a-97f7-e063-6294a90a91e22026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC500f239c-0460-a22b-e063-6294a90a1ba62026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDELifestar Pharma LLC67e31675-1da2-4acf-84ac-77522b02f0b92026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
AMITRIPTYLINE HYDROCHLORIDEAMITRIPTYLINE HYDROCHLORIDEAurobindo Pharma Limited8085a37f-3c76-4f74-aab3-9a929a7eb1c22026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.451b8742-8b3c-4335-9075-c1d8313cd3d02026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.b2f822aa-23c0-4833-afc8-f5a611b9ad5a2026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.ba6a83c4-2993-40ca-bb8f-2d6c5c3e3e262026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLC43450e62-d8c1-b39e-e063-6294a90a42ee2026-01-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDENorthwind Health Company, LLCf7e4ac7b-17bc-dae8-e053-6394a90a9cb62026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutions085baad2-d1c7-499e-b553-7477befd04d02025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionsace6748d-735c-4e6e-b327-a20101fd23d42025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAdvagen Pharma Ltd651bd090-a420-4dd8-89b0-4cb766c144c22025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAmerican Health Packaging98cc0bf3-ae5b-47cc-992f-9157fed7c3f42025-11-25Boxed warning, Adverse reactionsExact identifier
rxcui: 856834
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEAiPing Pharmaceutical, Inc.33807ee6-8443-4613-8bbe-d66f6010fc602025-11-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 3 of 3 · 84 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d22879c5-925a-42e0-9d48-55a422192983amitriptyline HCl 25 MG Oral Tablet [PSN] · amitriptyline hydrochloride 25 MG Oral Tablet [SCD]21Amitriptyline Hydrochloride Tablets, USP20231218
f6914a05-6a47-2ffb-e053-2a95a90a8e17amitriptyline HCl 25 MG Oral Tablet [PSN] · amitriptyline hydrochloride 25 MG Oral Tablet [SCD]21Amitriptyline Hydrochloride Tablets, USP Rx Only20230310
f410257d-b3be-31d6-e053-2995a90a3274amitriptyline HCl 25 MG Oral Tablet [PSN] · amitriptyline hydrochloride 25 MG Oral Tablet [SCD]21Amitriptyline Hydrochloride Tablets, USP20230206
d441d278-2c54-4a22-83a3-4627d49aaae4amitriptyline HCl 25 MG Oral Tablet [PSN] · amitriptyline hydrochloride 25 MG Oral Tablet [SCD]21Amitriptyline Hydrochloride Tablets, USP20100201