Amitriptyline Hydrochloride

Product NDC: 50090-2972
11-digit product format: 500902972
Labeler code: 50090
Product ID: 50090-2972_8b647d06-1f11-4694-b4cc-14f0cdfb64c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amitriptyline hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA086009
Marketing category: ANDA
Marketing start: 1978-04-10
Marketing end: 0000-00-00
Substance: AMITRIPTYLINE 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#

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	50090-2972		I	Inactivated by FDA		2026-08-11
excluded package	package	50090-2972	50090-2972-0	I	Inactivated by FDA		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`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	50090-2972-0	`9bebd1f3094a…`	`5416666fcb17…`

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
A086009-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	Approved before 1982
A086009-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	Approved before 1982
A086009-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982
A086009-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	Approved before 1982
A086009-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	Approved before 1982
A086009-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	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
A086009-001	AB
A086009-002	AB
A086009-003	AB
A086009-004	AB
A086009-005	AB
A086009-006	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 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A086009-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086009-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086009-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086009-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086009-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086009-006	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086009-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086009-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086009-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086009-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086009-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086009-006	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086009-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086009-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086009-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086009-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086009-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086009-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086009-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086009-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086009-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086009-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086009-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086009-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086009-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086009-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086009-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086009-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086009-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086009-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086009-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A086009-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A086009-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A086009-004	AB	1	`b00525d2431f…`

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
50090-2972-0	2020-01-31	C162847	48780-1	9d75b9d1-1299-f424-e053-dadaa90a57ce	2868cad2-19c7-49bf-92d5-52094a782ec5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-2972-0	Amitriptyline Hydrochloride	33 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	33		5
50090-2972-0	Amitriptyline Hydrochloride	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2972-0	EA - Each	50090-2972	38022c06-6210-47e7-ba6a-f904d7d93fd9	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2972	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	5	Legacy NDC, 2 package rows	20190225_2868cad2-19c7-49bf-92d5-52094a782ec5.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Aurobindo Pharma Limited	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086009 application number: ANDA086009

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
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	2868cad2-19c7-49bf-92d5-52094a782ec5	5
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	2868cad2-19c7-49bf-92d5-52094a782ec5	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50090-2972-0	50090297200	33 in 1 BOX, UNIT-DOSE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride - A-S Medication Solutions	A-S Medication Solutions	2018-06-29	HUMAN PRESCRIPTION DRUG LABEL	5