Nortriptyline Hydrochloride

Product NDC: 51862-945
11-digit product format: 518620945
Labeler code: 51862
Product ID: 51862-945_a7804223-4fad-40cf-96c1-c3ee2cbd1fd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nortriptyline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: ANDA073556
Marketing category: ANDA
Marketing start: 2019-12-12
Marketing end: 0000-00-00
Substance: NORTRIPTYLINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51862-945		D	Discontinued by firm	2026-10-15
excluded package	package	51862-945	51862-945-01	D	Discontinued by firm	2026-10-15
excluded package	package	51862-945	51862-945-05	D	Discontinued by firm	2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 33 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-945-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51862-945-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-945-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51862-945-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51862-945-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51862-945-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51862-945-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51862-945-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51862-945-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51862-945-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51862-945-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	51862-945-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51862-945-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	51862-945-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51862-945-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	51862-945-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51862-945-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	51862-945-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51862-945-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	51862-945-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51862-945-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	51862-945-01	`367a005e9d99…`	`383a685ebd0f…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073556-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	1992-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073556-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB	1992-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073556-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB	1992-03-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073556-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB	1992-03-30	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A073556-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A073556-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A073556-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A073556-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A073556-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A073556-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A073556-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A073556-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A073556-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073556-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073556-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A073556-004	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-945-01	EA - Each	51862-945	b2ff44ab-42ef-4914-886f-c9da9d37794a	1	2020-03-10

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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	8a294b63-7268-4105-8e17-a59ef889d572	2024-07-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	1a904ddf-574a-8a24-e063-6394a90aba3b	2024-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	4442f029-dd5e-4834-9b01-eb8c638ce4b1	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	8811104b-6223-4ea6-a9c6-61d63a21b3cd	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Dr. Reddy's Laboratories Inc.	b1d9582c-742c-91a8-c2b3-bbdb21220470	2023-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073556 application number: ANDA073556
Nortriptyline Hydrochloride	NORTRIPTYLINE HYDROCHLORIDE	Mayne Pharma Inc.	765d726b-fd4b-4ef7-afd7-9e7e9bf8cae6	2021-03-24	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
198045	nortriptyline HCl 10 MG Oral Capsule	PSN	b857696e-5227-1a15-e053-2a95a90a1a1b	1
198045	nortriptyline 10 MG Oral Capsule	SCD	b857696e-5227-1a15-e053-2a95a90a1a1b	1
198045	nortriptyline (as nortriptyline HCl) 10 MG Oral Capsule	SY	b857696e-5227-1a15-e053-2a95a90a1a1b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-945-01	51862094501	100 CAPSULE in 1 BOTTLE, PLASTIC (51862-945-01)	100 capsule	2019-12-12	0000-00-00	No	No	Current
51862-945-05	51862094505	500 CAPSULE in 1 BOTTLE, PLASTIC (51862-945-05)	500 capsule	2019-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nortriptyline Hydrochloride Capsules, USP	Bryant Ranch Prepack	2024-09-06	HUMAN PRESCRIPTION DRUG LABEL	102
Nortriptyline Hydrochloride Capsules, USP	Mayne Pharma Inc. \| Piramal Pharma Limited	2024-08-22	HUMAN PRESCRIPTION DRUG LABEL	3
Nortriptyline Hydrochloride Capsules, USP	Preferred Pharmaceuticals Inc.	2024-07-23	HUMAN PRESCRIPTION DRUG LABEL	3
Nortriptyline Hydrochloride Capsules, USP	NuCare Pharmaceuticals,Inc.	2021-01-07	HUMAN PRESCRIPTION DRUG LABEL	1