Nortriptyline Hydrochloride

Product NDC: 33261-692
11-digit product format: 332610692
Labeler code: 33261
Product ID: 33261-692_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: 50 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#

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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33261-692		I	Inactivated by FDA	2026-08-03
excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	2026-08-03
excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 2 · 63 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	33261-692		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	33261-692	33261-692-30	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	33261-692	33261-692-60	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`

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…`

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
33261-692-30	2020-01-31	C162847	48780-1	9d75b9d0-75fd-f424-e053-dadaa90a57ce	NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP 0810 0811 0812 0813 Rx only
33261-692-60	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
33261-692-30	Nortriptyline Hydrochloride	30 in 1 BOTTLE, PLASTIC	CAPSULE	30		1
33261-692-60	Nortriptyline Hydrochloride	60 in 1 BOTTLE, PLASTIC	CAPSULE	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-692-30	EA - Each	33261-692	fdc5baa0-6888-4a2e-9197-e8ee78cb53b1	1	2015-10-02
33261-692-60	EA - Each	33261-692	759bfe8b-532d-4bf6-8b02-18ef27e28c35	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
33261-692	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 2 package rows	20140128_79d0c09a-8557-44a2-bb87-2ddc496edc1b.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	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
33261-692-30	33261069230	30 in 1 BOTTLE, PLASTIC	Historical
33261-692-60	33261069260	60 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