AMITRIPTYLINE HYDROCHLORIDE

Product NDC: 69158-002
11-digit product format: 691580002
Labeler code: 69158
Product ID: 69158-002_3171e373-6375-4467-b3f0-872e9221a773
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMITRIPTYLINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: GLENVIEW PHARMA INC.
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: 2018-12-31
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	69158-002		I	Inactivated by FDA		2026-08-07
excluded package	package	69158-002	69158-002-00	I	Inactivated by FDA		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 · 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	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69158-002-00	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69158-002-00	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69158-002-00	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69158-002-00	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69158-002-00	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69158-002-00	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69158-002-00	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69158-002-00	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69158-002-00	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69158-002-00	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69158-002-00	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69158-002-00	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69158-002-00	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69158-002-00	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69158-002-00	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69158-002-00	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69158-002-00	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69158-002-00	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69158-002-00	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
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	69158-002-00	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	69158-002-00	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	69158-002-00	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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e5006e90-7f2e-4341-bcdb-f83027a8fc39	Product name	6	20240611
6f1277d7-db3a-63fa-be84-d390d1482706	Product name	1	20140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69158-002-00	2020-01-31	C162847	48780-1	9d75b9d0-f81d-f424-e053-dadaa90a57ce	AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69158-002-00	AMITRIPTYLINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69158-002-00	EA - Each	69158-002	d73574c4-1576-4b56-885d-b114c8bf9433	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69158-002	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [GLENVIEW PHARMA INC.]	4	Legacy NDC, 1 package rows	20140910_94e984da-3b08-406f-8c10-e78844fca1ff.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	94e984da-3b08-406f-8c10-e78844fca1ff	4
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	94e984da-3b08-406f-8c10-e78844fca1ff	4
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	94e984da-3b08-406f-8c10-e78844fca1ff	4
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	94e984da-3b08-406f-8c10-e78844fca1ff	4
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	94e984da-3b08-406f-8c10-e78844fca1ff	4
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	94e984da-3b08-406f-8c10-e78844fca1ff	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
69158-002-00	69158000200	100 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP	GLENVIEW PHARMA INC.	2014-09-03	HUMAN PRESCRIPTION DRUG LABEL	4