Nortriptyline Hydrochloride

Product NDC
63629-4276
11-digit product format
636294276
Labeler code
63629
Product ID
63629-4276_84632f22-a990-4066-99b9-c08e91d5bf92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nortriptyline Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074132
Marketing category
ANDA
Marketing start
1995-04-05
Substance
NORTRIPTYLINE HYDROCHLORIDE
Active strength
50 mg/1
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 HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii00FN6IH15D
Rxcui198046

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
63629-4276-1Nortriptyline Hydrochloride30 in 1 BOTTLECAPSULE307
63629-4276-2Nortriptyline Hydrochloride60 in 1 BOTTLECAPSULE607
63629-4276-3Nortriptyline Hydrochloride90 in 1 BOTTLECAPSULE907
63629-4276-4Nortriptyline Hydrochloride28 in 1 BOTTLECAPSULE287
63629-4276-5Nortriptyline Hydrochloride120 in 1 BOTTLECAPSULE1207

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4276-1EA - Each63629-4276d5658656-8021-456e-ba47-b36b1f1e29f712012-07-24
63629-4276-2EA - Each63629-4276877d2592-3ed6-4516-b6f0-96c42d1d30ee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NORTRIPTYLINE HYDROCHLORIDEACTIVE INGREDIENT00FN6IH15DNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
NORTRIPTYLINEACTIVE MOIETYBL03SY4LXBNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
GELATININACTIVE INGREDIENT2G86QN327LNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
SHELLACINACTIVE INGREDIENT46N107B71ONORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198046nortriptyline HCl 50 MG Oral CapsulePSN8eef261f-5c78-a88f-37c4-46e6b0e0f0ee7
198046nortriptyline 50 MG Oral CapsuleSCD8eef261f-5c78-a88f-37c4-46e6b0e0f0ee7
198046nortriptyline (as nortriptyline HCl) 50 MG Oral CapsuleSY8eef261f-5c78-a88f-37c4-46e6b0e0f0ee7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63629-4276-16362942760130 CAPSULE in 1 BOTTLE (63629-4276-1) 30 capsule2011-08-01NoNoHistorical
63629-4276-26362942760260 CAPSULE in 1 BOTTLE (63629-4276-2) 60 capsule2011-08-01NoNoHistorical
63629-4276-36362942760390 CAPSULE in 1 BOTTLE (63629-4276-3) 90 capsule2010-06-07NoNoHistorical
63629-4276-46362942760428 CAPSULE in 1 BOTTLE (63629-4276-4) 28 capsule2010-06-07NoNoHistorical
63629-4276-563629427605120 CAPSULE in 1 BOTTLE (63629-4276-5) 120 capsule2010-06-07NoNoHistorical