Nortriptyline Hydrochloride

Product NDC: 21695-600
11-digit product format: 216950600
Labeler code: 21695
Product ID: 21695-600_03601ccc-4a9a-4cb9-9028-281bbed42182
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nortriptyline Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA073556
Marketing category: ANDA
Marketing start: 1992-03-30
Marketing end: 0000-00-00
Substance: NORTRIPTYLINE HYDROCHLORIDE
Active strength: 75 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	21695-600		I	Inactivated by FDA		2026-08-03
excluded package	package	21695-600	21695-600-30	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 · 44 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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`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	21695-600-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-600-30	`110d247fa046…`	`a55b01930146…`

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…`

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
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-600-30	2019-09-24	C162847	48780-1	934fe258-4767-48b1-e053-8cdaa90a720a	Nortriptyline

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-600-30	Nortriptyline Hydrochloride	30 in 1 BOTTLE	CAPSULE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-600-30	EA - Each	21695-600	d4c76d20-11bb-4c40-b8e6-5e3eeace19cf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NORTRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	00FN6IH15D	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
NORTRIPTYLINE	ACTIVE MOIETY	BL03SY4LXB	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
EDETATE CALCIUM DISODIUM	INACTIVE INGREDIENT	25IH6R4SGF	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-600	NORTRIPTYLINE HYDROCHLORIDE CAPSULE [REBEL DISTRIBUTORS CORP]	2	Legacy NDC, 1 package rows	20110805_375f06ce-97ea-4b4c-8d90-6b2091be18fa.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
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
198045	nortriptyline HCl 10 MG Oral Capsule	PSN	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2
317136	nortriptyline HCl 25 MG Oral Capsule	PSN	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2
198046	nortriptyline HCl 50 MG Oral Capsule	PSN	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2
198047	nortriptyline HCl 75 MG Oral Capsule	PSN	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2
198045	nortriptyline 10 MG Oral Capsule	SCD	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2
317136	nortriptyline 25 MG Oral Capsule	SCD	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2
198046	nortriptyline 50 MG Oral Capsule	SCD	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2
198047	nortriptyline 75 MG Oral Capsule	SCD	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2
198045	nortriptyline (as nortriptyline HCl) 10 MG Oral Capsule	SY	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2
317136	nortriptyline (as nortriptyline HCl) 25 MG Oral Capsule	SY	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2
198046	nortriptyline (as nortriptyline HCl) 50 MG Oral Capsule	SY	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2
198047	nortriptyline (as nortriptyline HCl) 75 MG Oral Capsule	SY	375f06ce-97ea-4b4c-8d90-6b2091be18fa	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-600-30	21695060030	30 in 1 BOTTLE	Historical