FDA.reportPublic FDA data

NDC 51672-4004-01 - 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
51672-4004
Requested NDC
51672-4004-01
Package NDCs from labels
51672-4004-6, 51672-4004-5, 51672-4004-1, 51672-4004-2, 51672-4004-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.
Effective date
2026-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nortriptyline Hydrochloride Capsules, USPSun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries, Ltd.2026-07-15HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride Capsules, USPREMEDYREPACK INC.2025-01-13HUMAN PRESCRIPTION DRUG LABEL
Nortriptyline Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2023-10-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4004-1Nortriptyline Hydrochloride100 in 1 BOTTLECAPSULE10010
51672-4004-2Nortriptyline Hydrochloride500 in 1 BOTTLECAPSULE50010
51672-4004-5Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE9010
51672-4004-6Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4004NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]10Current NDC, Legacy NDC, 4 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
51672-4004-1EA - Each51672-400435e9c47b-d08c-4ab8-b1cf-69da7225ecd412016-02-04
51672-4004-2EA - Each51672-40049adc480b-4a07-4b4e-a1a1-6dd34b3f737212015-05-05
51672-4004-5EA - Each51672-40043f1c96c5-552a-43ec-9d69-e74547b96d8c12013-02-13
51672-4004-6EA - Each51672-400437162d6f-2274-453e-862a-dd0996a2a0df12013-02-13

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

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 139 · 2,765 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
HeadacheMELILOTUS OFFICINALIS, SPIGELIA ANTHELMIA, ALLIUM CEPA, BELLADONNA, BRYONIA (ALBA), CIMICIFUGA RACEMOSA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MAGNESIA PHOSPHORICA, NUX VOMICA, SANGUINARIA CANADENSIS, SILICEA, TARENTULA CUBENSISBioActive Nutritionals, Inc.918bc478-78a2-41e1-b123-f5350cf8f43a2026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c282026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075520
ndc (package): 51672-4004-2
ndc (package): 51672-4003-5
ndc (package): 51672-4002-1
ndc (package): 51672-4003-6
ndc (package): 51672-4004-1
ndc (package): 51672-4002-4
ndc (package): 51672-4002-2
ndc (package): 51672-4004-6
ndc (package): 51672-4001-2
ndc (package): 51672-4002-5
ndc (package): 51672-4001-5
ndc (package): 51672-4002-6
ndc (package): 51672-4001-1
ndc (package): 51672-4004-5
ndc (package): 51672-4001-6
ndc (package): 51672-4003-1
ndc (package): 51672-4003-2
ndc (product): 51672-4003
ndc (product): 51672-4004
ndc (product): 51672-4001
ndc (product): 51672-4002
ndc11 (package): 51672400401
rxcui: 317136
rxcui: 198046
rxcui: 198045
rxcui: 198047
spl id: 56a6d4f3-e026-2d59-e063-6394a90a45be
spl set id: aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28
unii: 00FN6IH15D
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB3 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a233350-729a-1e0c-e063-6394a90ad48c2026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB9 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23f72b-4c33-a100-e063-6294a90ac6322026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB10 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a241d80-b9d2-ea93-e063-6294a90ab3662026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB8 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23f728-a824-48a6-e063-6394a90acae72026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB4 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23653a-2481-bd15-e063-6394a90a71332026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB5 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a238f2d-efa9-01d1-e063-6294a90aae6f2026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB1 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a2105a7-6ae8-ed6e-e063-6394a90a3d072026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB2 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a22c1c6-912a-7222-e063-6294a90a54062026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB7 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23b531-ac53-f0df-e063-6294a90afcf92026-07-08WarningsExact identifier
unii: 15FIX9V2JP