FDA.reportPublic FDA data

NDC 71335-2802-05 - Amitriptyline Hydrochloride

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
71335-2802
Requested NDC
71335-2802-05
Package NDCs from labels
71335-2802-1, 71335-2802-2, 71335-2802-3, 71335-2802-4, 71335-2802-5, 71335-2802-6, 71335-2802-7, 71335-2802-8, 71335-2802-05
Manufacturer
Bryant Ranch Prepack
Effective date
2025-10-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amitriptyline Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2025-10-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2802-1Amitriptyline Hydrochloride100 in 1 BOTTLETABLET, COATED1001
71335-2802-2Amitriptyline Hydrochloride30 in 1 BOTTLETABLET, COATED301
71335-2802-3Amitriptyline Hydrochloride60 in 1 BOTTLETABLET, COATED601
71335-2802-4Amitriptyline Hydrochloride90 in 1 BOTTLETABLET, COATED901
71335-2802-5Amitriptyline Hydrochloride20 in 1 BOTTLETABLET, COATED201
71335-2802-6Amitriptyline Hydrochloride28 in 1 BOTTLETABLET, COATED281
71335-2802-7Amitriptyline Hydrochloride56 in 1 BOTTLETABLET, COATED561
71335-2802-8Amitriptyline Hydrochloride180 in 1 BOTTLETABLET, COATED1801

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 109 · 2,177 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.61b29703-cfc2-45c7-ae24-7bf3b77e85872026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212654
rxcui: 856762
unii: 26LUD4JO9K
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.e0aa02a9-3e2d-44c5-a6b9-843c801022492026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856853
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.4e520c63-1cf6-40f6-a51c-3f9b0e1813422026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
rxcui: 856853
rxcui: 856783
rxcui: 856845
rxcui: 856773
rxcui: 856762
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.c072c1b3-ed8a-4f1e-ba6c-580a2b2c8f582026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212654
rxcui: 856834
unii: 26LUD4JO9K
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.bb02d7b8-8f1a-4cc4-b763-223e6894f02c2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856762
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.4132f91e-6f24-476a-9028-bab86ad0598e2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
unii: 26LUD4JO9K
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEREMEDYREPACK INC.5dc3c2d7-60a2-4754-be33-1f9401c925a42026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856845
unii: 26LUD4JO9K
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC598f6ffb-45c3-3cfc-e063-6294a90a56d12026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856834
unii: 26LUD4JO9K
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDECoupler LLC598f900c-552b-5653-e063-6294a90aff532026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856762
unii: 26LUD4JO9K
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionse0d5b1f6-c1f2-4d5b-a1c3-aebe77843df22026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212654
rxcui: 856834
unii: 26LUD4JO9K
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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