FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
75907-071
11-digit product format
759070071
Labeler code
75907
Product ID
75907-071_8630467c-de24-9d2e-ac96-ce9afeaca9b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA073556
Marketing category
ANDA
Marketing start
2023-11-17
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nortriptyline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198045, 198046, 198047, 317136

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
53e88688-54e1-9681-22b8-e499bd715088Product name220210729
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-071-01Nortriptyline Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE1001
75907-071-05Nortriptyline Hydrochloride500 in 1 BOTTLE, PLASTICCAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75907-071-01EA - Each75907-07166c88f22-042b-4fb5-90cd-1fc1cddf19ad12024-02-14
75907-071-05EA - Each75907-071c3f05b03-7ee3-4ef8-b289-51b2ad9c979012024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-071NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DR. REDDY'S LABORATORIES INC.]1Current NDC, 2 package rows20231117_b1d9582c-742c-91a8-c2b3-bbdb21220470.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSN4442f029-dd5e-4834-9b01-eb8c638ce4b1100
198046nortriptyline 50 MG Oral CapsuleSCD4442f029-dd5e-4834-9b01-eb8c638ce4b1100
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY4442f029-dd5e-4834-9b01-eb8c638ce4b1100
198046nortriptyline HCl 50 MG Oral CapsulePSN1ba55931-5597-90ea-e063-6294a90a5a2f3
198046nortriptyline HCl 50 MG Oral CapsulePSNc7cce83f-9508-49de-a442-246ad18ddeda3
198046nortriptyline 50 MG Oral CapsuleSCD1ba55931-5597-90ea-e063-6294a90a5a2f3
198046nortriptyline 50 MG Oral CapsuleSCDc7cce83f-9508-49de-a442-246ad18ddeda3
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYc7cce83f-9508-49de-a442-246ad18ddeda3
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY1ba55931-5597-90ea-e063-6294a90a5a2f3
198045nortriptyline HCl 10 MG Oral CapsulePSNb1d9582c-742c-91a8-c2b3-bbdb212204701
198045nortriptyline HCl 10 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline HCl 25 MG Oral CapsulePSNb1d9582c-742c-91a8-c2b3-bbdb212204701
317136nortriptyline HCl 25 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline HCl 50 MG Oral CapsulePSN2fffe23d-37f8-34fe-e063-6294a90a7b6c1
198046nortriptyline HCl 50 MG Oral CapsulePSNb1d9582c-742c-91a8-c2b3-bbdb212204701
198046nortriptyline HCl 50 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline HCl 75 MG Oral CapsulePSNb02eb04a-83ee-45b0-b755-187fde2698c31
198047nortriptyline HCl 75 MG Oral CapsulePSNb1d9582c-742c-91a8-c2b3-bbdb212204701
198045nortriptyline 10 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198045nortriptyline 10 MG Oral CapsuleSCDb1d9582c-742c-91a8-c2b3-bbdb212204701
317136nortriptyline 25 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline 25 MG Oral CapsuleSCDb1d9582c-742c-91a8-c2b3-bbdb212204701
198046nortriptyline 50 MG Oral CapsuleSCD2fffe23d-37f8-34fe-e063-6294a90a7b6c1
198046nortriptyline 50 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline 50 MG Oral CapsuleSCDb1d9582c-742c-91a8-c2b3-bbdb212204701
198047nortriptyline 75 MG Oral CapsuleSCDb1d9582c-742c-91a8-c2b3-bbdb212204701
198047nortriptyline 75 MG Oral CapsuleSCDb02eb04a-83ee-45b0-b755-187fde2698c31
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYb1d9582c-742c-91a8-c2b3-bbdb212204701
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYb1d9582c-742c-91a8-c2b3-bbdb212204701
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY2fffe23d-37f8-34fe-e063-6294a90a7b6c1
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYb1d9582c-742c-91a8-c2b3-bbdb212204701
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYb1d9582c-742c-91a8-c2b3-bbdb212204701
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYb02eb04a-83ee-45b0-b755-187fde2698c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-071-0175907007101100 CAPSULE in 1 BOTTLE, PLASTIC (75907-071-01) 100 capsule2023-11-17NoNoCurrent
75907-071-0575907007105500 CAPSULE in 1 BOTTLE, PLASTIC (75907-071-05) 500 capsule2023-11-17NoNoCurrent