FDA.reportPublic FDA data

NDC 16729-171-10 - 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
16729-171
Requested NDC
16729-171-10
Package NDCs from labels
16729-171-10, 16729-171-01, 16729-171-17
Manufacturer
Northwind Health Company, LLC
Effective date
2026-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMITRIPTYLINE HYDROCHLORIDE - Northwind Health Company, LLCNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride Tablets, USPPreferred Pharamaceuticals Inc.2025-01-03HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline HCL - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE HYDROCHLORIDE - Bryant Ranch PrepackBryant Ranch Prepack2024-08-19HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride Tablets, USPREMEDYREPACK INC.2024-08-09HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride Tablets, USPNuCare Pharmaceuticals,Inc.2024-07-18HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride Tablets, USPNuCare Pharmaceuticals,Inc.2024-07-18HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE HYDROCHLORIDE - A-S Medication SolutionsA-S Medication Solutions2024-02-01HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE HYDROCHLORIDE - St. Mary's Medical Park PharmacySt. Mary's Medical Park Pharmacy2023-12-08HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride Tablets, USPRPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE HYDROCHLORIDE - Denton Pharma, Inc. dba Northwind PharmaceuticalsDenton Pharma, Inc. dba Northwind Pharmaceuticals2023-01-02HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride Tablets, USPAccord Healthcare Inc. | Intas Pharmaceuticals Limited. | Intas Pharmaceuticals Limited2022-11-05HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE HYDROCHLORIDE - Direct_RxDirect_Rx2022-10-05HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE HYDROCHLORIDE - Direct_RxDirect_Rx2022-10-05HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE HYDROCHLORIDE - Lake Erie Medical DBA Quality Care Products LLCLake Erie Medical DBA Quality Care Products LLC2022-09-19HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE HYDROCHLORIDE - Proficient Rx LPProficient Rx LP2022-05-02HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride Tablets, USPNuCare Pharmaceuticals, Inc.2020-01-22HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride - DIRECT RXDIRECT RX2019-03-29HUMAN PRESCRIPTION DRUG LABEL
Amitriptyline Hydrochloride Tablets, USPNuCare Pharmaceuticals, Inc. | NuCare Pharmaceuticals,Inc.2017-07-13HUMAN PRESCRIPTION DRUG LABEL
AMITRIPTYLINE HYDROCHLORIDE - Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC2017-04-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-171-01AMITRIPTYLINE HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1008
16729-171-10AMITRIPTYLINE HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
16729-171-17AMITRIPTYLINE HYDROCHLORIDE1000 in 1 BOTTLETABLET, FILM COATED10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-171AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]8Current NDC, Legacy NDC, 3 package rows20221106_1e6d2c80-fbc8-444e-bdd3-6a91fe1b95bd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-171-01EA - Each16729-17101c910ac-e802-470b-94a9-b769d71e908a12015-01-05
16729-171-17EA - Each16729-1719f689193-ba9b-4935-a2a7-71cb20ac924712015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMITRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT26LUD4JO9KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
AMITRIPTYLINEACTIVE MOIETY1806D8D52KAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE INC.]3

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 2 of 142 · 2,838 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
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
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
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
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Amitriptyline HydrochlorideAMITRIPTYLINE HYDROCHLORIDEA-S Medication Solutionse0d5b1f6-c1f2-4d5b-a1c3-aebe77843df22026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
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
Cerebellum Thalamus A AurmCEREBELLUM THALAMUS A AURUMUriel Pharmacy Inc.e1c395b8-9221-401f-8980-c91ff88434582026-08-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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