Amitriptyline Hydrochloride

Product NDC: 0615-0830
11-digit product format: 006150830
Labeler code: 0615
Product ID: 0615-0830_ac604638-a8d2-4925-b940-8387dc27d488
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA085968
Marketing category: ANDA
Marketing start: 1977-11-29
Marketing end: 0000-00-00
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 50 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	0615-0830		D	Discontinued by firm		2026-08-07
excluded package	package	0615-0830	0615-0830-39	D	Discontinued by firm		2026-08-07

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 · 30 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-0830-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-0830-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-0830-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-0830-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-0830-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-0830-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-0830-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-0830-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-0830-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-0830-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-0830-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-0830-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-0830-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-0830-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-0830-39	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS
A085968-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982
A085968-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
A085968-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982
A085968-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982
A085968-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	RLD, Approved before 1982
A085968-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A085968-001	AB
A085968-002	AB
A085968-003	AB
A085968-004	AB
A085968-005	AB
A085968-006	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 6 · 226 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A085968-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085968-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085968-003	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085968-004	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085968-005	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085968-006	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-003	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-004	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-005	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-006	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085968-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085968-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085968-003	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085968-004	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085968-005	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085968-006	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-003	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-004	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-005	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-006	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-003	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-004	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-005	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-006	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-003	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-004	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-005	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-006	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085968-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085968-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085968-003	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085968-004	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, Approved before 1982	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 226 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	A085968-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085968-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085968-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085968-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085968-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A085968-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A085968-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A085968-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085968-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085968-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085968-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085968-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A085968-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A085968-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A085968-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A085968-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085968-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085968-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085968-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A085968-004	AB	1	`2680178bc6a6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-0830-39	2021-02-24	C162847	48780-1	9d75b9d0-e1fa-f424-e053-dadaa90a57ce	Amitriptyline Hydrochloride Tablets, USP
0615-0830-39	2020-01-31	C162847	48780-1	9d75b9d0-e1fa-f424-e053-dadaa90a57ce	Amitriptyline Hydrochloride Tablets, USP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	5

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	471f3a17-baaa-cc35-e063-6294a90aed96	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085968 application number: ANDA085968
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	1523a2b4-f9d6-4d3c-a370-df579ed36911	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085968 application number: ANDA085968
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	d7bfeb47-2482-4217-b522-df4444499133	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085968 application number: ANDA085968
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Sandoz Inc	705a2bae-031d-4218-82fe-4346542c0baa	2025-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 085968 application number: ANDA085968

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE	549-18-8	AMITRIPTYLINE HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP	NCS HealthCare of KY, Inc dba Vangard Labs	2014-12-02	HUMAN PRESCRIPTION DRUG LABEL	5