FDA.reportPublic FDA data

NDC 51672-4002-01 - Nortriptyline 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
51672-4002
Requested NDC
51672-4002-01
Package NDCs from labels
51672-4002-6, 51672-4002-4, 51672-4002-5, 51672-4002-1, 51672-4002-2, 51672-4002-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-08-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nortriptyline Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2026-08-18HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride Capsules, USPSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.2026-07-15HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride - Northwind Health Company, LLCNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride - Quality Care Products LLCQuality Care Products LLC2024-12-17HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride - American Health PackagingAmerican Health Packaging2024-08-07HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride Capsules, USPNuCare Pharmaceuticals, Inc. | NuCarePharmaceuticals, Inc.2024-07-19HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride Capsules, USPPD-Rx Pharmaceuticals, Inc.2024-03-25HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2024-03-17HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride Capsules, USPREMEDYREPACK INC.2024-02-13HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride - AvPAKAvPAK2024-01-08HUMAN PRESCRIPTION DRUG LABEL
NORTRIPTYLINE HCI - Direct_RxDirect_Rx2022-10-05HUMAN PRESCRIPTION DRUG LABEL
NORTRIPTYLINE HCI - Direct_RxDirect_Rx2022-10-05HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride Capsules, USPPreferred Pharmaceuticals Inc.2022-09-14HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride Capsules, USPREMEDYREPACK INC.2022-07-06HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride - Proficient Rx LPProficient Rx LP2022-07-01HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride - Clinical Solutions Wholesale, LLCClinical Solutions Wholesale, LLC2020-07-26HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline HCL - Direct_RxDirect_Rx2019-03-11HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride Capsules, USPSt. Mary's Medical Park Pharmacy | Taro Pharmaceutical Industries, Ltd.2018-11-16HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride - Unit Dose ServicesUnit Dose Services2018-04-19HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride - Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC2016-11-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4002-1Nortriptyline Hydrochloride100 in 1 BOTTLECAPSULE10010
51672-4002-2Nortriptyline Hydrochloride500 in 1 BOTTLECAPSULE50010
51672-4002-4Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE6010
51672-4002-5Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE9010
51672-4002-6Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4002NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]10Current NDC, Legacy NDC, 5 package rows20200508_aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4002-1EA - Each51672-4002aa566477-3aad-44a5-ad7c-6be836523d6b12016-02-04
51672-4002-5EA - Each51672-4002217e5126-c662-4b12-8e51-06da3c2afc4512013-02-13
51672-4002-6EA - Each51672-40029481fdef-5327-4e13-bb32-e582e0beaed612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nortriptyline HydrochlorideACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
NortriptylineACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
aluminum oxideINACTIVE INGREDIENTLMI26O6933NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
D&C Yellow NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Blue NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Green NO. 3INACTIVE INGREDIENT3P3ONR6O1SNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOANORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
gelatinINACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
magnesium stearateINACTIVE INGREDIENT70097M6I30NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
shellacINACTIVE INGREDIENT46N107B71ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
starch, cornINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]8
Nortriptyline HydrochlorideACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
NortriptylineACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
D&C Yellow NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
FD&C Blue NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
FD&C Blue NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
FD&C Red NO. 40INACTIVE INGREDIENTWZB9127XOANORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
shellacINACTIVE INGREDIENT46N107B71ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.]1

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 83 of 137 · 2,727 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products BM55DAPHNE INDICA, NATRUM PHOS, SILICA MARINA, TABACUMBestmade Natural Products2c751942-5b36-8558-e063-6294a90af87a2025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact identifier
unii: 15FIX9V2JP
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDOCSMEDI Co., Ltd.a02f8865-e7be-4ef4-b09c-dad8466397642025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Lemon QuinceLEMON QUINCEUriel Pharmacy Inc332e4a40-e0f3-11de-8a39-0800200c9a662025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
unii: 15FIX9V2JP
Hydration ComplexBETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f60a2ab8-4146-4995-9bc6-be2660b175402025-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD293a6a6c-adf3-452d-92f5-3baceb619e392025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior594982d5-b4bf-4889-99b7-b3cd58fa80312025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior26f1dcde-209e-4c6d-9577-1f3d3e21595f2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dioradba288c-e94f-4b26-8f7d-336f3e5108bd2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
SUNSTATION USA SPF-30 SPORT SUNSCREEN-SUNSTATION USA SPF-30 SPORT SUNSCREEN-Sunstation USA, LLC2bd84b92-dcf0-404f-e063-6294a90a10602025-01-16Exact identifier
unii: 15FIX9V2JP
Emme Diane Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEEmme Diane, Incab53ad98-b667-4447-8177-724dbf771e802025-01-16WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD2be51fdf-c3f2-463b-8c7d-bda07db17e1b2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESpectrum Aesthetics Laser Training LLC026b9b30-ef08-bf2e-e063-6394a90a54a62025-01-14WarningsExact identifier
unii: 15FIX9V2JP
D-34OYSTER SHELL CALCIUM CARBONATE, CRUDE, CALCIUM FLUORIDE, CALCIUM HYPOPHOSPHITE, TRIBASIC CALCIUM PHOSPHATE, HEKLA LAVA, DAPHNE MEZEREUM BARK, MERCURIC OXIDE, SILICON DIOXIDE, AND MATRICARIA CHAMOMILLADNA Labs, Inc.607e21a3-2229-48fa-b12c-ebd3130b99962025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-33ATROPA BELLADONNA, BUFO BUFO CUTANEOUS GLAND, COPPER, ANEMONE PRATENSIS, SILICON DIOXIDE, AND ZINCDNA Labs, Inc.26f9bf6d-6038-42e8-b8c1-6c94ac4929af2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-86ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDEDNA Labs, Inc.54fa62d3-c129-4826-a794-f3dcc6b855bf2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-57ARSENIC TRIIODIDE, PHOSPHORUS, TEUCRIUM SCORODONIA FLOWERING TOP, SILICON DIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, AND LYCOPODIUM CLAVATUM SPOREDNA Labs, Inc.81cc16e7-921b-4b57-abeb-c44b9d72e4f32025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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