Nortriptyline Hydrochloride

Product NDC: 72789-425
Requested package NDC: 72789-425-30
11-digit product format: 727890425
Labeler code: 72789
Product ID: 72789-425_4123bbc5-c72a-e70d-e063-6294a90a2fb4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nortriptyline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA073556
Marketing category: ANDA
Marketing start: 2023-11-17
Substance: NORTRIPTYLINE HYDROCHLORIDE
Active strength: 25 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.

Product history page 1 of 5 · 164 observed 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
2026-02-19 14:30 UTC	2026-02	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A073556-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073556-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073556-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073556-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073556-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073556-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073556-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073556-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073556-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073556-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073556-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073556-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073556-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073556-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073556-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073556-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073556-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073556-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073556-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073556-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073556-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073556-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073556-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073556-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073556-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073556-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073556-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073556-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073556-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073556-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073556-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073556-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073556-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073556-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073556-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073556-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073556-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073556-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073556-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073556-004	AB	1	`d06236e962d9…`

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	25 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
317136	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
dbb3cc4d-c36d-495d-b9fc-e5513b2f6b93	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	Strength	SPL version
72789-425-30	Nortriptyline Hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72789-425-30	EA - Each	72789-425	2a97bcb0-180a-476e-a468-fb1e4323832d	1	2024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72789-425	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	2	Current NDC, 1 package rows	20240808_dbb3cc4d-c36d-495d-b9fc-e5513b2f6b93.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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 ndc (package): 72789-425-30 ndc (product): 72789-425 ndc11 (package): 72789042530
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
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

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	dbb3cc4d-c36d-495d-b9fc-e5513b2f6b93	3
317136	nortriptyline 25 MG Oral Capsule	SCD	dbb3cc4d-c36d-495d-b9fc-e5513b2f6b93	3
317136	nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule	SY	dbb3cc4d-c36d-495d-b9fc-e5513b2f6b93	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72789-425-30	72789042530	30 CAPSULE in 1 BOTTLE, PLASTIC (72789-425-30)	30 capsule	2024-08-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nortriptyline Hydrochloride Capsules, USP	PD-Rx Pharmaceuticals, Inc.	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	3