FDA.reportPublic FDA data

Nortriptyline Hydrochloride

Product NDC
0121-0678
11-digit product format
001210678
Labeler code
0121
Product ID
0121-0678_49445e55-d381-44c5-9e91-392f530d6dfc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA075606
Marketing category
ANDA
Marketing start
2000-08-23
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
10 mg/5mL
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nortriptyline Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NORTRIPTYLINE HYDROCHLORIDE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui312036

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
de76de11-1019-6138-2d8a-16fa566ae22aProduct name220241009
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
53e88688-54e1-9681-22b8-e499bd715088Product name220210729
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0678-16Nortriptyline Hydrochloride473 mL in 1 BOTTLESOLUTION47315

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0678-16ML - Milliliter0121-06789d42db72-745b-4417-9156-98680332a6fc12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Nortriptyline HydrochlorideACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
NortriptylineACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
alcoholINACTIVE INGREDIENT3K9958V90MNORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPNORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUNORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
sorbitolINACTIVE INGREDIENT506T60A25RNORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RNORTRIPTYLINE HYDROCHLORIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0678NORTRIPTYLINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]14Current NDC, Legacy NDC, 1 package rows20241116_3fcabf90-357a-4a06-b680-9572dc28bcfe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312036nortriptyline HCl 10 MG in 5 mL Oral SolutionPSN3fcabf90-357a-4a06-b680-9572dc28bcfe15
312036nortriptyline 2 MG/ML Oral SolutionSCD3fcabf90-357a-4a06-b680-9572dc28bcfe15
312036nortriptyline (as nortriptyline hydrochloride) 10 MG per 5 ML Oral SolutionSY3fcabf90-357a-4a06-b680-9572dc28bcfe15
312036nortriptyline HCl 10 MG per 5 ML Oral SolutionSY3fcabf90-357a-4a06-b680-9572dc28bcfe15
312036nortriptyline HCl 20 MG per 10 ML Oral SolutionSY3fcabf90-357a-4a06-b680-9572dc28bcfe15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0678-1600121067816473 mL in 1 BOTTLE (0121-0678-16) 473 ml2000-08-230000-00-00NoNoCurrent