Nortriptyline Hydrochloride

Product NDC: 33261-804
11-digit product format: 332610804
Labeler code: 33261
Product ID: 33261-804_7f8fad0a-267b-4284-9de3-14ddd77d9ac0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nortriptyline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA074132
Marketing category: ANDA
Marketing start: 1995-04-05
Marketing end: 0000-00-00
Substance: NORTRIPTYLINE HYDROCHLORIDE
Active strength: 75 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	33261-804		I	Inactivated by FDA		2026-08-03
excluded package	package	33261-804	33261-804-30	I	Inactivated by FDA		2026-08-03

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 · 42 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	33261-804-30	`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	33261-804-30	`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	33261-804-30	`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	33261-804-30	`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	33261-804-30	`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	33261-804-30	`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	33261-804-30	`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	33261-804-30	`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	33261-804-30	`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	33261-804-30	`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	33261-804-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-804-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-804-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-804-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-804-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	33261-804-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	33261-804-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	33261-804-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	33261-804-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	33261-804-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	33261-804-30	`9bebd1f3094a…`	`5416666fcb17…`

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.

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RS	1995-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RS	1995-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RS	1995-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RS	1995-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RS	1995-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB	RS	1995-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1995-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1995-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1995-03-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074132-001	NORTRIPTYLINE HYDROCHLORIDE	EQ 10MG BASE	CAPSULE / ORAL	AB		1995-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074132-002	NORTRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE	CAPSULE / ORAL	AB		1995-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074132-003	NORTRIPTYLINE HYDROCHLORIDE	EQ 50MG BASE	CAPSULE / ORAL	AB		1995-03-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074132-004	NORTRIPTYLINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE / ORAL	AB		1995-03-27	`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	A074132-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074132-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074132-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074132-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074132-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074132-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074132-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074132-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074132-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074132-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074132-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074132-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074132-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074132-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074132-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074132-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074132-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074132-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074132-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074132-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074132-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074132-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074132-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074132-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074132-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074132-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074132-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074132-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074132-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074132-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074132-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074132-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074132-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074132-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074132-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074132-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074132-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074132-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074132-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074132-004	AB	1	`d06236e962d9…`

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
33261-804-30	2020-01-31	C162847	48780-1	9d75b9d0-75fd-f424-e053-dadaa90a57ce	NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33261-804-30	Nortriptyline Hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-804-30	EA - Each	33261-804	cc101d7e-7c51-481d-b756-45c5ca93046b	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NORTRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	00FN6IH15D	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
NORTRIPTYLINE	ACTIVE MOIETY	BL03SY4LXB	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	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 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
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	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
33261-804	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20140128_79d0c09a-8557-44a2-bb87-2ddc496edc1b.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 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

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	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	Status
33261-804-30	33261080430	30 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only	Aidarex Pharmaceuticals LLC	2014-01-20	HUMAN PRESCRIPTION DRUG LABEL	1