Nortriptyline Hydrochloride

Product NDC: 0093-0812
11-digit product format: 000930812
Labeler code: 0093
Product ID: 0093-0812_314d74dc-7394-40b9-be81-cb67b6e925a1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nortriptyline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
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: 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
Ingredient	Strength
NORTRIPTYLINE HYDROCHLORIDE	50 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	00FN6IH15D
Rxcui	198045, 198046, 198047, 317136

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
de76de11-1019-6138-2d8a-16fa566ae22a	Product name	2	20241009
53e88688-54e1-9681-22b8-e499bd715088	Product name	2	20210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0093-0812-01	Nortriptyline Hydrochloride	100 in 1 BOTTLE	CAPSULE	100		23
0093-0812-05	Nortriptyline Hydrochloride	500 in 1 BOTTLE	CAPSULE	500		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0812-01	EA - Each	0093-0812	5594ae40-ce84-4571-bb9d-f251ffe346fa	1	2012-07-24
0093-0812-05	EA - Each	0093-0812	20ea56f3-ea48-488b-b9ae-fd677cb55c32	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NORTRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	00FN6IH15D	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
NORTRIPTYLINE	ACTIVE MOIETY	BL03SY4LXB	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA INC]	11
NORTRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	00FN6IH15D	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
NORTRIPTYLINE	ACTIVE MOIETY	BL03SY4LXB	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]	3
NORTRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	00FN6IH15D	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
NORTRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	00FN6IH15D	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
NORTRIPTYLINE	ACTIVE MOIETY	BL03SY4LXB	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
NORTRIPTYLINE	ACTIVE MOIETY	BL03SY4LXB	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0093-0812	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]	22	Current NDC, Legacy NDC, 2 package rows	20250522_b58d473a-b19f-4d2a-b1ae-dd398d7a29e1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
00FN6IH15D	NORTRIPTYLINE HYDROCHLORIDE	894-71-3	NORTRIPTYLINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198045	nortriptyline HCl 10 MG Oral Capsule	PSN	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
317136	nortriptyline HCl 25 MG Oral Capsule	PSN	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
198046	nortriptyline HCl 50 MG Oral Capsule	PSN	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
198047	nortriptyline HCl 75 MG Oral Capsule	PSN	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
198045	nortriptyline 10 MG Oral Capsule	SCD	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
317136	nortriptyline 25 MG Oral Capsule	SCD	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
198046	nortriptyline 50 MG Oral Capsule	SCD	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
198047	nortriptyline 75 MG Oral Capsule	SCD	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
198045	nortriptyline (as nortriptyline HCl) 10 MG Oral Capsule	SY	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
317136	nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule	SY	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
198046	nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule	SY	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
198047	nortriptyline (as nortriptyline HCl) 75 MG Oral Capsule	SY	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	23
198046	nortriptyline HCl 50 MG Oral Capsule	PSN	8eef261f-5c78-a88f-37c4-46e6b0e0f0ee	7
198046	nortriptyline HCl 50 MG Oral Capsule	PSN	b387ba49-fd3f-4488-86e8-9b81e85ab232	7
198046	nortriptyline 50 MG Oral Capsule	SCD	8eef261f-5c78-a88f-37c4-46e6b0e0f0ee	7
198046	nortriptyline 50 MG Oral Capsule	SCD	b387ba49-fd3f-4488-86e8-9b81e85ab232	7
198046	nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule	SY	8eef261f-5c78-a88f-37c4-46e6b0e0f0ee	7
198046	nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule	SY	b387ba49-fd3f-4488-86e8-9b81e85ab232	7
198046	nortriptyline HCl 50 MG Oral Capsule	PSN	9386627f-3522-425b-b0b0-f4d9d30ad98e	5
198046	nortriptyline 50 MG Oral Capsule	SCD	9386627f-3522-425b-b0b0-f4d9d30ad98e	5
198046	nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule	SY	9386627f-3522-425b-b0b0-f4d9d30ad98e	5
198046	nortriptyline HCl 50 MG Oral Capsule	PSN	a2cf7783-7019-49ea-ab55-796674d94546	3
198046	nortriptyline 50 MG Oral Capsule	SCD	a2cf7783-7019-49ea-ab55-796674d94546	3
198046	nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule	SY	a2cf7783-7019-49ea-ab55-796674d94546	3
317136	nortriptyline HCl 25 MG Oral Capsule	PSN	79d0c09a-8557-44a2-bb87-2ddc496edc1b	1
198046	nortriptyline HCl 50 MG Oral Capsule	PSN	79d0c09a-8557-44a2-bb87-2ddc496edc1b	1
198047	nortriptyline HCl 75 MG Oral Capsule	PSN	79d0c09a-8557-44a2-bb87-2ddc496edc1b	1
317136	nortriptyline 25 MG Oral Capsule	SCD	79d0c09a-8557-44a2-bb87-2ddc496edc1b	1
198046	nortriptyline 50 MG Oral Capsule	SCD	79d0c09a-8557-44a2-bb87-2ddc496edc1b	1
198047	nortriptyline 75 MG Oral Capsule	SCD	79d0c09a-8557-44a2-bb87-2ddc496edc1b	1
317136	nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule	SY	79d0c09a-8557-44a2-bb87-2ddc496edc1b	1
198046	nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule	SY	79d0c09a-8557-44a2-bb87-2ddc496edc1b	1
198047	nortriptyline (as nortriptyline HCl) 75 MG Oral Capsule	SY	79d0c09a-8557-44a2-bb87-2ddc496edc1b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-0812-01	00093081201	100 CAPSULE in 1 BOTTLE (0093-0812-01)	100 capsule	1995-04-05	0000-00-00	No	No	Current
0093-0812-05	00093081205	500 CAPSULE in 1 BOTTLE (0093-0812-05)	500 capsule	1995-04-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nortriptyline Hydrochloride Capsules, USP Rx only	A-S Medication Solutions	2026-03-24	HUMAN PRESCRIPTION DRUG LABEL	3
NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only	Bryant Ranch Prepack	2026-03-10	HUMAN PRESCRIPTION DRUG LABEL	7
Nortriptyline Hydrochloride Capsules, USP Rx only	Teva Pharmaceuticals USA, Inc.	2025-09-30	HUMAN PRESCRIPTION DRUG LABEL	23
NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP Rx only	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	7
NORTRIPTYLINE HYDROCHLORIDE	DIRECT RX	2016-06-22	HUMAN PRESCRIPTION DRUG LABEL	5
NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only	Aidarex Pharmaceuticals LLC	2014-01-20	HUMAN PRESCRIPTION DRUG LABEL	1

Nortriptyline Hydrochloride

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#