Nortriptyline Hydrochloride

Product NDC: 71335-2772
11-digit product format: 713352772
Labeler code: 71335
Product ID: 71335-2772_08c0027e-4168-43c2-a7d9-f6555bf250ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nortriptyline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA073556
Marketing category: ANDA
Marketing start: 2023-11-17
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

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	Approval date
A073556-001	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30
A073556-002	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30
A073556-003	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30
A073556-004	NORTRIPTYLINE HYDROCHLORIDE	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073556-001	AB
A073556-002	AB
A073556-003	AB
A073556-004	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	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`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	A073556-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A073556-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A073556-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A073556-004	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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	1e32f284-a5b2-4ebf-9d9e-0e9a40b46ade	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	3c57301f-5128-295e-e063-6394a90ad99e	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline HCL	NORTRIPTYLINE HCL	Direct_rx	1bcf2f7b-974f-54ad-e063-6394a90a28d9	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	27e96d6c-b311-45d2-b879-65c6a4efcfba	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	21770082-7a99-520d-e063-6394a90ab9cb	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline HCL	NORTRIPTYLINE HCL	Direct_rx	1b55fd23-36f8-10e4-e063-6394a90aa49a	2026-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline HCL	NORTRIPTYLINE HCL	Direct_rx	1ba55931-5597-90ea-e063-6294a90a5a2f	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	ba4edb34-82ac-4c98-8abd-fd6176838c78	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	dbb3cc4d-c36d-495d-b9fc-e5513b2f6b93	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	6b055ebf-ed9e-44c5-bc03-6b6480d14377	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556 ndc (product): 71335-2772
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	4852a754-2fc1-4c10-a414-dc8a1dfd66a2	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	c7cce83f-9508-49de-a442-246ad18ddeda	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	f684e9c8-eca7-4e27-872d-c0adea19de9a	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	60763e7a-d22c-47d5-a260-f64bd4a4f654	2025-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	36b00c00-5fbd-c14b-e063-6294a90a49b7	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Coupler LLC	2fffe23d-37f8-34fe-e063-6294a90a7b6c	2025-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Coupler LLC	2ccb3fd0-53c9-6015-e063-6294a90a3fd6	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Asclemed USA, Inc.	b02eb04a-83ee-45b0-b755-187fde2698c3	2025-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Coupler LLC	2c92511f-0127-c74e-e063-6394a90a1214	2025-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	661ec73c-d893-446a-83c3-218b06889962	2024-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556

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	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
00FN6IH15D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198045	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6b055ebf-ed9e-44c5-bc03-6b6480d14377	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
de76de11-1019-6138-2d8a-16fa566ae22a	Product name	2	20241009
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
53e88688-54e1-9681-22b8-e499bd715088	Product name	2	20210729

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-2772-1	Nortriptyline Hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	1
71335-2772-2	Nortriptyline Hydrochloride	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	1
71335-2772-3	Nortriptyline Hydrochloride	90 in 1 BOTTLE, PLASTIC	CAPSULE	90	1
71335-2772-4	Nortriptyline Hydrochloride	100 in 1 BOTTLE, PLASTIC	CAPSULE	100	1
71335-2772-5	Nortriptyline Hydrochloride	120 in 1 BOTTLE, PLASTIC	CAPSULE	120	1
71335-2772-6	Nortriptyline Hydrochloride	15 in 1 BOTTLE, PLASTIC	CAPSULE	15	1

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	6b055ebf-ed9e-44c5-bc03-6b6480d14377	1
198045	nortriptyline 10 MG Oral Capsule	SCD	6b055ebf-ed9e-44c5-bc03-6b6480d14377	1
198045	nortriptyline (as nortriptyline HCl) 10 MG Oral Capsule	SY	6b055ebf-ed9e-44c5-bc03-6b6480d14377	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2772-1	71335277201	30 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-1)	30 capsule	2025-10-13	No	No	Current
71335-2772-2	71335277202	60 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-2)	60 capsule	2025-10-13	No	No	Current
71335-2772-3	71335277203	90 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-3)	90 capsule	2025-10-13	No	No	Current
71335-2772-4	71335277204	100 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-4)	100 capsule	2025-10-13	No	No	Current
71335-2772-5	71335277205	120 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-5)	120 capsule	2025-10-13	No	No	Current
71335-2772-6	71335277206	15 CAPSULE in 1 BOTTLE, PLASTIC (71335-2772-6)	15 capsule	2025-10-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nortriptyline Hydrochloride Capsules, USP	Bryant Ranch Prepack	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	1