FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
71205-770
11-digit product format
712050770
Labeler code
71205
Product ID
71205-770_30263e15-de21-4db4-aceb-59d619909e82
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-05
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198045

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
71205-770-30Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE301
71205-770-60Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE601
71205-770-90Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-770-30EA - Each71205-770233e0eea-fb2d-4519-be52-05d00d8a823612023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-770NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PROFICIENT RX LP]1Current NDC, 3 package rows20230318_30263e15-de21-4db4-aceb-59d619909e82.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198045nortriptyline HCl 10 MG Oral CapsulePSN30263e15-de21-4db4-aceb-59d619909e821
198045nortriptyline 10 MG Oral CapsuleSCD30263e15-de21-4db4-aceb-59d619909e821
198045nortriptyline (as nortriptyline HCl) 10 MG Oral CapsuleSY30263e15-de21-4db4-aceb-59d619909e821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-770-307120507703030 CAPSULE in 1 BOTTLE (71205-770-30) 30 capsule2023-03-10NoNoCurrent
71205-770-607120507706060 CAPSULE in 1 BOTTLE (71205-770-60) 60 capsule2023-03-10NoNoCurrent
71205-770-907120507709090 CAPSULE in 1 BOTTLE (71205-770-90) 90 capsule2023-03-10NoNoCurrent