FDA.reportPublic FDA data

NDC 63304-202-01 - 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
63304-202
Requested NDC
63304-202-01
Package NDCs from labels
63304-202-01
Manufacturer
Ranbaxy Laboratories Limited
Effective date
2008-01-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nortriptyline Hydrochloride - Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited2008-01-04HUMAN PRESCRIPTION DRUG LABELING
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-202-01Nortriptyline Hydrochloride480 mL in 1 BOTTLESOLUTION4801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-202NORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES LIMITED]11 package rows20080111_ced93eb0-e8b6-44b8-9d2c-e2afa92500f7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-202-01ML - Milliliter63304-20215aaeefe-0d59-4cfe-8885-0d0debe8053112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nortriptyline hydrochlorideACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES LIMITED]1
NortriptylineACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES LIMITED]1
alcoholINACTIVE INGREDIENT3K9958V90MNORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES LIMITED]1
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMNORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES LIMITED]1
flavorsINACTIVE INGREDIENTNORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES LIMITED]1
sorbitolINACTIVE INGREDIENT506T60A25RNORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES LIMITED]1
waterINACTIVE INGREDIENT059QF0KO0RNORTRIPTYLINE HYDROCHLORIDE (NORTRIPTYLINE HYDROCHLORIDE) SOLUTION [RANBAXY LABORATORIES LIMITED]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 1 of 1 ยท 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharma3fcabf90-357a-4a06-b680-9572dc28bcfe2026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312036
Nortriptyline HydrochlorideNORTRIPTYLINE HYDROCHLORIDEAdvagen Pharma Ltdbef9e24d-e730-4801-ab25-75e7d6bde2252026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 312036
7FADF3B9-4987-E587-E295-FB02952A3514ced93eb0-e8b6-44b8-9d2c-e2afa92500f72008-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 7FADF3B9-4987-E587-E295-FB02952A3514
spl set id: ced93eb0-e8b6-44b8-9d2c-e2afa92500f7

Reported adverse events (FAERS/openFDA)#

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