Amitriptyline Hydrochloride

Product NDC: 50090-4005
11-digit product format: 500904005
Labeler code: 50090
Product ID: 50090-4005_d8bc1bbb-9f8c-439b-b3b8-000fa58fdcf3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA210086
Marketing category: ANDA
Marketing start: 2017-12-26
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 15 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
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	50090-4005-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4005-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4005-8	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-4005-4	`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	50090-4005-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4005-0	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4005-8	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-4005-4	`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	50090-4005-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4005-0	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4005-8	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-4005-4	`1332a3947898…`	`d4bfe170f9cd…`

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	Approval date
A210086-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-10-06
A210086-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-10-06
A210086-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-06
A210086-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-10-06
A210086-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-06
A210086-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210086-001	AB
A210086-002	AB
A210086-003	AB
A210086-004	AB
A210086-005	AB
A210086-006	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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210086-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210086-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210086-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210086-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210086-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210086-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210086-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210086-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210086-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210086-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210086-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210086-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2017-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2017-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210086-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2017-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210086-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2017-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210086-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2017-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210086-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2017-10-06	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A210086-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210086-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210086-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210086-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210086-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210086-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210086-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210086-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210086-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210086-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210086-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210086-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210086-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210086-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210086-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210086-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210086-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210086-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210086-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210086-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amitriptyline Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMITRIPTYLINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
26LUD4JO9K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856834	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0067b698-ee1d-4524-b1cc-af1028d13736	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e5006e90-7f2e-4341-bcdb-f83027a8fc39	Product name	6	20240611
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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, Related label table
NDC	Effective	Related label
50090-4005-0	2024-06-12	Amitriptyline Hydrochloride Tablets, USP
50090-4005-1	2024-06-12	Amitriptyline Hydrochloride Tablets, USP
50090-4005-4	2024-06-12	Amitriptyline Hydrochloride Tablets, USP
50090-4005-8	2024-06-12	Amitriptyline Hydrochloride Tablets, USP
50090-4005-0	2023-01-30	Amitriptyline Hydrochloride Tablets, USP
50090-4005-1	2023-01-30	Amitriptyline Hydrochloride Tablets, USP
50090-4005-4	2023-01-30	Amitriptyline Hydrochloride Tablets, USP
50090-4005-8	2023-01-30	Amitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-4005-0	Amitriptyline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	10
50090-4005-1	Amitriptyline Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	10
50090-4005-4	Amitriptyline Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	10
50090-4005-8	Amitriptyline Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4005-0	EA - Each	50090-4005	314ebc8c-2c90-422c-9876-5aabd54e375e	1	2021-12-08
50090-4005-1	EA - Each	50090-4005	dc52b16e-8327-490b-92db-03dda76793ae	1	2021-12-08
50090-4005-4	EA - Each	50090-4005	e554b2af-2268-4125-977d-6f137e0c20e4	1	2021-12-08
50090-4005-8	EA - Each	50090-4005	e2133667-4db7-46a1-8cf5-d8e0c6955ca4	1	2021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4005	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	10	Current NDC, Legacy NDC, 4 package rows	20240613_0067b698-ee1d-4524-b1cc-af1028d13736.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Coupler LLC	5070fa18-ecc9-de14-e063-6394a90a372e	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210086 application number: ANDA210086
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	American Health Packaging	98cc0bf3-ae5b-47cc-992f-9157fed7c3f4	2025-11-25	Boxed warning, Adverse reactions	Exact identifier application applno (ANDA): 210086 application number: ANDA210086
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	43454445-b9cf-1378-e063-6294a90a1cc6	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210086 application number: ANDA210086
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Zydus Lifesciences Limited	4159b10e-f589-486c-969d-9b4544b098b5	2025-10-04		Exact identifier application applno (ANDA): 210086 application number: ANDA210086
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northstar Rx LLC.	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210086 application number: ANDA210086
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	73669354-babc-4687-a4fe-ad0fc1f863ba	2025-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210086 application number: ANDA210086
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	b793f1f8-c1f9-46f0-8156-1a4957db3a1f	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210086 application number: ANDA210086
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	0067b698-ee1d-4524-b1cc-af1028d13736	2024-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210086 application number: ANDA210086 ndc (product): 50090-4005
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	5e8c8c5f-4964-4642-ad4b-69a75b2c8a02	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210086 application number: ANDA210086
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	d22879c5-925a-42e0-9d48-55a422192983	2023-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210086 application number: ANDA210086

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
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	0067b698-ee1d-4524-b1cc-af1028d13736	10
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	0067b698-ee1d-4524-b1cc-af1028d13736	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4005-0	50090400500	30 TABLET, FILM COATED in 1 BOTTLE (50090-4005-0)	2018-12-27	0000-00-00	No	No	Current
50090-4005-1	50090400501	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4005-1)	2017-12-26	0000-00-00	No	No	Current
50090-4005-4	50090400504	60 TABLET, FILM COATED in 1 BOTTLE (50090-4005-4)	2019-02-12	0000-00-00	No	No	Current
50090-4005-8	50090400508	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-4005-8)	2017-12-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP	A-S Medication Solutions	2024-06-12	HUMAN PRESCRIPTION DRUG LABEL	10