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 110 of 136 · 2,713 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEA-S Medication Solutions53346b9c-40a1-4b5b-8df0-0b393661fb852024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075520
rxcui: 198045
unii: 00FN6IH15D
REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/OOCTINOXATE, TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10f7ec01-541b-a15a-e063-6294a90aa9df2024-02-09WarningsExact identifier
unii: 15FIX9V2JP
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Deseret Biologicals, Inc.6d934960-63c6-4536-bde3-38c26f8083dc2024-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden HourTITANIUM DIOXIDECOOLA, LLCedfda0f5-0f72-5cc7-e053-2a95a90ae38d2024-02-02WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Summer CrushZINC OXIDECOOLA, LLCedc6754e-dabb-5bff-e053-2a95a90a73902024-02-02WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Skinny DipZINC OXIDECOOLA, LLCee01f936-81a9-a54d-e053-2a95a90a52272024-02-02WarningsExact identifier
unii: 15FIX9V2JP
toty Solaria MineralTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe9d590d8-e71a-0715-e053-2a95a90a5acf2024-02-01WarningsExact identifier
unii: 15FIX9V2JP
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCf1868790-c70b-4979-974d-3ce0ffe99e362024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 317136
unii: 00FN6IH15D
SiliceaSILICON DIOXIDESEVENE USA0805d866-ce1a-4f54-8a44-83d4902e8c0d2024-01-30WarningsExact identifier
unii: ETJ7Z6XBU4
ATOMY DERMA CALMING SUNTITANIUM DIOXIDEATOMY CO., LTD.fd5fc3ba-6e7c-4e48-8e65-47c03141df452024-01-30WarningsExact identifier
unii: 15FIX9V2JP
Sleep TightADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Dr. Donna Restivo DCb5955fbc-71f8-4fe0-9df0-42f337ab9c7d2024-01-18WarningsExact identifier
unii: ETJ7Z6XBU4
Shunly Radiant Translucent SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC20783833-ee7f-4425-b4ab-ab61cda5b2c82024-01-17WarningsExact identifier
unii: 15FIX9V2JP
Shunly Radiant Translucent Tinted SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC1aeb5e05-730c-4c5c-b164-ad9347b0cd932024-01-17WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc4a243c9f-ca88-47fb-8777-1da79c001c732024-01-16WarningsExact identifier
unii: 15FIX9V2JP
MY MEDIC SPF 30 REEF FRIENDLY SUNSCREENHOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACIDSled Distribution, LLCec252876-7205-83ec-e053-2a95a90a14632024-01-15WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDECosmetique Active Productionfd2541e1-c409-40a8-9e3f-6ff69084ea662024-01-15WarningsExact identifier
unii: 15FIX9V2JP
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Incbc72048a-4786-44c2-97ce-0220822816542024-01-15WarningsExact identifier
unii: 15FIX9V2JP
Revlon Colorstay Light Cover FoundationHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE,ZINC OXIDERevlonb0006b5f-0d56-0efb-e053-2a95a90a59792024-01-12WarningsExact identifier
unii: 15FIX9V2JP
PREVAGE CITY SMARTTITANIUM DIOXIDE, ZINC OXIDEREVLONb60c9b41-cf32-ee94-e053-2a95a90abab02024-01-12WarningsExact identifier
unii: 15FIX9V2JP
CERAMIDE MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDEREVLONb3ad9686-47ed-4b60-e053-2995a90abcdd2024-01-12WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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