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 43 of 139 · 2,779 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0400b-8ad9-654b-e063-6294a90ad0402025-12-16Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c00301-ee41-333c-e063-6294a90a61d52025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c078fa-05f9-ad80-e063-6394a90af3bb2025-12-16Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c0a55d-16d3-086a-e063-6394a90a30cf2025-12-16Exact identifier
unii: 15FIX9V2JP
Really Great Lip ShieldTITANIUM DIOXIDE, ZINC OXIDEJEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION36c1341d-fbf5-56a5-e063-6294a90aa0452025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c465ea-979b-9474-e063-6394a90ab3f82025-12-16Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c4a27b-96e9-4f30-e063-6294a90a56552025-12-16Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDESAN JOSE MEDICAL SPA37ef19e5-1775-a8d5-e063-6394a90acaef2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEBABYFACE LLC36d69eb5-59b4-14a0-e063-6394a90a0a492025-12-16Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d6141c-6967-d779-e063-6294a90af0a72025-12-16Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c043e0-fd6c-5f7a-e063-6294a90a88992025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0c1ca-80a8-9d37-e063-6294a90a824f2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0f5df-6bfb-3c0d-e063-6294a90a2e5f2025-12-16Exact identifier
unii: 15FIX9V2JP
Mold AntigenALTERNARIA ALTERNATA, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, BOLETUS SAT, BOTRYTIS CINEREA, CLADOSPORIUM METANIGRUM, FUSARIUM OXYSPORUM, HELMINTHOSPORIUM, MUCOR MUECEDO, PULLULARIA PULLULANS, RHIZOPUS NIGRICANS, USTILAGO MAYDIS, ARSENICUM ALB, CANDIDA ALB, CARBO AN, LACHESIS, LYCOPODIUM, MERC SOLUB, NITRICUM AC, PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, THUJA OCCNatural Creations, Inc9dd6f22e-45b0-4771-80f7-6f530c96350d2025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
ScarCALENDULA, GRAPHITES, HYPERICUM PERFORATUM, STAPHYSAGRIA, SILICEA, THIOSINAMINUMNatural Creations, Incf83f2234-24dc-4fb9-972e-ada049d940ed2025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
Total Eye 3-In-1 Renewal Therapy SPF 35TITANIUM DIOXIDE AND ZINC OXIDEColorescience4b116cc4-94d2-4bfc-b7f9-5f486a194c6c2025-12-16WarningsExact identifier
unii: 15FIX9V2JP
SCROPHULOUS HPBARIUM CARBONATE, BROMINE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CONIUM MACULATUM FLOWERING TOP, FERROUS IODIDE, MERCURIUS SOLUBILIS, PHYTOLACCA AMERICANA ROOT, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDENatural Creations, Inc.fb30a5cf-7d25-48f3-a6e6-0cc4c1f418922025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
INJURY HPARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, HYPERICUM PERFORATUM, PHOSPHORUS, RANCID BEEF, SILICON DIOXIDE, DELPHINIUM STAPHISAGRIA SEED, COMFREY ROOTNatural Creations, Inc.10be3e95-da2f-4340-8c12-2e676472a94d2025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
SINUS HPAMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, CALCIUM SULFIDE, POTASSIUM DICHROMATE, POTASSIUM SULFATE, LYCOPODIUM CLAVATUM SPORE, MERCURIUS SOLUBILIS, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, THUJA OCCIDENTALIS LEAFY TWIGNatural Creations, Inc.f017da22-74c2-40f4-adcc-5e84b6ea52912025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4
RespirasodeBRYONIA, DULCAMARA, KALI CARB, SANGUINARIA, BELLADONNA, BROMIUM, CANDIDA ALB, CANDIDA PARAP, CONIUM, LYCOPODIUM, PULSATILLA, SECALE, SILICEA, STICTA, SULPHUR, USTILAGO MAIDISNatural Creations, Incce06327f-7e5e-420a-9b61-0d410f9e10d62025-12-16WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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