Nortriptyline Hydrochloride

Product NDC: 67544-078
Requested package NDC: 67544-078-53
11-digit product format: 675440078
Labeler code: 67544
Product ID: 67544-078_00c8012b-9b3c-44b9-8f0e-be0b6cef2bec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nortriptyline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA074132
Marketing category: ANDA
Marketing start: 1995-04-06
Marketing end: 0000-00-00
Substance: NORTRIPTYLINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67544-078	67544-078-53	I	Inactivated by FDA		2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074132-001	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27
A074132-002	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27
A074132-003	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27
A074132-004	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RS	1995-03-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A074132-001	AB
A074132-002	AB
A074132-003	AB
A074132-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RS	1995-03-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A074132-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074132-004	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	dd1f4d6f-14cc-44c0-b9d3-bb3d17b557fa	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	522d0cd8-d84d-4961-a525-4527fce44c3c	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	a2cf7783-7019-49ea-ab55-796674d94546	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	8eef261f-5c78-a88f-37c4-46e6b0e0f0ee	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Coupler LLC	4c21abdb-f3e9-9037-e063-6294a90af4b4	2026-03-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	Direct Rx	017f7717-e160-4142-9a5a-1a2bd9776707	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	American Health Packaging	d111c36d-98ed-4f0d-97ea-86fe9048deee	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	686d15d0-6434-42ec-8c78-f45d617d294c	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	962f3f54-0556-4509-a231-ca62cb01bec8	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	43a81887-42b8-43b5-b58a-3f3df2e9949b	2025-11-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	b58d473a-b19f-4d2a-b1ae-dd398d7a29e1	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	af950b46-07df-4de6-a221-d3d7059b87a1	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	e047f990-c374-4f8f-8583-c615f92545e2	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	2f9fc7a0-163a-4a05-84a7-7999a41ecb1f	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	b387ba49-fd3f-4488-86e8-9b81e85ab232	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	f1868790-c70b-4979-974d-3ce0ffe99e36	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	30263e15-de21-4db4-aceb-59d619909e82	2023-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074132 application number: ANDA074132

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67544-078-30	2023-01-30	C162847	48780-1	f386c649-e2a4-0266-e053-dadaa90a7c1a	NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only
67544-078-53	2023-01-30	C162847	48780-1	f386c649-e2a4-0266-e053-dadaa90a7c1a	NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only
67544-078-60	2023-01-30	C162847	48780-1	f386c649-e2a4-0266-e053-dadaa90a7c1a	NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only
67544-078-70	2023-01-30	C162847	48780-1	f386c649-e2a4-0266-e053-dadaa90a7c1a	NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only
67544-078-80	2023-01-30	C162847	48780-1	f386c649-e2a4-0266-e053-dadaa90a7c1a	NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only
67544-078-92	2023-01-30	C162847	48780-1	f386c649-e2a4-0266-e053-dadaa90a7c1a	NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only
67544-078-94	2023-01-30	C162847	48780-1	f386c649-e2a4-0266-e053-dadaa90a7c1a	NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67544-078-30	Nortriptyline Hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	3
67544-078-53	Nortriptyline Hydrochloride	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	3
67544-078-60	Nortriptyline Hydrochloride	90 in 1 BOTTLE, PLASTIC	CAPSULE	90	3
67544-078-70	Nortriptyline Hydrochloride	120 in 1 BOTTLE, PLASTIC	CAPSULE	120	3
67544-078-80	Nortriptyline Hydrochloride	180 in 1 BOTTLE, PLASTIC	CAPSULE	180	3
67544-078-92	Nortriptyline Hydrochloride	270 in 1 BOTTLE, PLASTIC	CAPSULE	270	3
67544-078-94	Nortriptyline Hydrochloride	360 in 1 BOTTLE, PLASTIC	CAPSULE	360	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67544-078-30	EA - Each	67544-078	13d2862e-e103-4789-a586-f328012c8010	1	2013-02-13
67544-078-53	EA - Each	67544-078	8ef0bb7d-5acf-431a-959a-8b78f37ac12a	1	2013-02-13
67544-078-60	EA - Each	67544-078	1eb59aeb-562f-4ccc-9544-f77c5a3945b0	1	2013-02-13
67544-078-70	EA - Each	67544-078	3a0b7828-43f7-49b8-ba59-9d6a740499f4	1	2013-02-13
67544-078-80	EA - Each	67544-078	cc1915f9-b9ab-4d63-826d-0f6d494bab1f	1	2013-02-13
67544-078-92	EA - Each	67544-078	d1eea515-c875-402d-b8f8-d6d0ced8848e	1	2013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67544-078	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 7 package rows	20191224_e1f5e650-e83f-4343-a025-fc90f645a796.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
317136	nortriptyline HCl 25 MG Oral Capsule	PSN	e1f5e650-e83f-4343-a025-fc90f645a796	3
317136	nortriptyline 25 MG Oral Capsule	SCD	e1f5e650-e83f-4343-a025-fc90f645a796	3
317136	nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule	SY	e1f5e650-e83f-4343-a025-fc90f645a796	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67544-078-53	67544007853	60 CAPSULE in 1 BOTTLE, PLASTIC (67544-078-53)	60 capsule	2004-06-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only	Aphena Pharma Solutions - Tennessee, LLC	2019-12-20	HUMAN PRESCRIPTION DRUG LABEL	3