FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
70771-1615
11-digit product format
707711615
Labeler code
70771
Product ID
70771-1615_b2965133-3b71-4cdb-8676-235882e57beb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA213441
Marketing category
ANDA
Marketing start
2022-02-10
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
75 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 HYDROCHLORIDE75 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
53e88688-54e1-9681-22b8-e499bd715088Product name220210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1615-1Nortriptyline Hydrochloride100 in 1 BOTTLECAPSULE1002
70771-1615-3Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE302
70771-1615-5Nortriptyline Hydrochloride500 in 1 BOTTLECAPSULE5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1615NORTRIPTYLINE HYDROCHLORIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, Legacy NDC, 3 package rows20241212_f22dce73-b895-4fe2-8cf7-816dca93c246.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSNf22dce73-b895-4fe2-8cf7-816dca93c2462
317136nortriptyline HCl 25 MG Oral CapsulePSNf22dce73-b895-4fe2-8cf7-816dca93c2462
198046nortriptyline HCl 50 MG Oral CapsulePSNf22dce73-b895-4fe2-8cf7-816dca93c2462
198047nortriptyline HCl 75 MG Oral CapsulePSNf22dce73-b895-4fe2-8cf7-816dca93c2462
198045nortriptyline 10 MG Oral CapsuleSCDf22dce73-b895-4fe2-8cf7-816dca93c2462
317136nortriptyline 25 MG Oral CapsuleSCDf22dce73-b895-4fe2-8cf7-816dca93c2462
198046nortriptyline 50 MG Oral CapsuleSCDf22dce73-b895-4fe2-8cf7-816dca93c2462
198047nortriptyline 75 MG Oral CapsuleSCDf22dce73-b895-4fe2-8cf7-816dca93c2462
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSYf22dce73-b895-4fe2-8cf7-816dca93c2462
317136nortriptyline (as nortriptyline HCl) 25 MG Oral CapsuleSYf22dce73-b895-4fe2-8cf7-816dca93c2462
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSYf22dce73-b895-4fe2-8cf7-816dca93c2462
198047nortriptyline (as nortriptyline HCl) 75 MG Oral CapsuleSYf22dce73-b895-4fe2-8cf7-816dca93c2462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1615-170771161501100 CAPSULE in 1 BOTTLE (70771-1615-1) 100 capsule2022-02-100000-00-00NoNoCurrent
70771-1615-37077116150330 CAPSULE in 1 BOTTLE (70771-1615-3) 30 capsule2022-02-100000-00-00NoNoCurrent
70771-1615-570771161505500 CAPSULE in 1 BOTTLE (70771-1615-5) 500 capsule2022-02-100000-00-00NoNoCurrent