Amitriptyline Hydrochloride

Product NDC: 16714-259
11-digit product format: 167140259
Labeler code: 16714
Product ID: 16714-259_f089e8f9-aed0-4f80-812d-35a969447345
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northstar Rx LLC.
Application: ANDA210086
Marketing category: ANDA
Marketing start: 2021-08-25
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	50 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856762	Internal RxNorm lookup
856773	Internal RxNorm lookup
856783	Internal RxNorm lookup
856834	Internal RxNorm lookup
856845	Internal RxNorm lookup
856853	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
8ed28f42-e41a-45ca-a86f-849ebeb6ab80	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
6f1277d7-db3a-63fa-be84-d390d1482706	Product name	1	20140508
aa9828b2-adf8-0dd3-9f6c-b68f39e467c1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
16714-259-01	Amitriptyline Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100		4
16714-259-02	Amitriptyline Hydrochloride	1000 in 1 BOTTLE	TABLET, FILM COATED	1000		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-259-01	EA - Each	16714-259	01308ebe-56fe-4a4a-83c9-f7624a4d8171	1	2021-11-09
16714-259-02	EA - Each	16714-259	687507e6-f1b0-4214-8651-8c72d1bd20e3	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-259	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NORTHSTAR RX LLC.]	3	Current NDC, Legacy NDC, 2 package rows	20250418_8ed28f42-e41a-45ca-a86f-849ebeb6ab80.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 ndc (product): 16714-259
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
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
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	8ed28f42-e41a-45ca-a86f-849ebeb6ab80	4
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	b793f1f8-c1f9-46f0-8156-1a4957db3a1f	1
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	b793f1f8-c1f9-46f0-8156-1a4957db3a1f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-259-01	16714025901	100 TABLET, FILM COATED in 1 BOTTLE (16714-259-01)	2021-08-25	0000-00-00	No	No	Current
16714-259-02	16714025902	1000 TABLET, FILM COATED in 1 BOTTLE (16714-259-02)	2021-08-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP	Northstar Rx LLC. \| Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2025-06-17	HUMAN PRESCRIPTION DRUG LABEL	4
Amitriptyline Hydrochloride Tablets, USP	A-S Medication Solutions	2024-06-25	HUMAN PRESCRIPTION DRUG LABEL	1