Amitriptyline Hydrochloride

Product NDC: 51655-084
11-digit product format: 516550084
Labeler code: 51655
Product ID: 51655-084_4ab6d63f-7efb-0930-e063-6294a90af17e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA213999
Marketing category: ANDA
Marketing start: 2023-03-06
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A213999-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19
A213999-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19
A213999-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19
A213999-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19
A213999-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19
A213999-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213999-001	AB
A213999-002	AB
A213999-003	AB
A213999-004	AB
A213999-005	AB
A213999-006	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 · 204 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	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213999-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213999-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213999-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213999-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-02-19	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 204 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	A213999-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213999-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213999-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213999-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213999-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213999-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213999-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213999-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213999-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213999-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213999-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213999-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amitriptyline Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AMITRIPTYLINE HYDROCHLORIDE	10 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
856783	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
f67d6f73-88d7-2031-e053-2995a90a3b09	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-084-26	2026-01-29	C162847	48780-1	49896155-a27c-586f-e063-e6dba90add90	Amitriptyline Hydrochloride Tablets, USP
51655-084-52	2026-01-29	C162847	48780-1	49896155-a27c-586f-e063-e6dba90add90	Amitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51655-084-26	Amitriptyline Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90		5
51655-084-52	Amitriptyline Hydrochloride	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-084	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1	Current NDC, 2 package rows	20230404_f67d6f73-88d7-2031-e053-2995a90a3b09.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Coupler LLC	500f239c-0460-a22b-e063-6294a90a1ba6	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	9f9d6495-47ff-4dcf-9643-ebd5cd7499cb	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Lifestar Pharma LLC	67e31675-1da2-4acf-84ac-77522b02f0b9	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	f67d6f73-88d7-2031-e053-2995a90a3b09	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999 ndc (product): 51655-084
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	f8236cd1-1b60-4a66-e053-6294a90afeb0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	f7e4ac7b-17bc-dae8-e053-6394a90a9cb6	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999
Amitriptyline HCL	AMITRIPTYLINE HCL	Direct_Rx	23ab2afe-06c1-fa61-e063-6394a90abcf8	2024-10-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213999 application number: ANDA213999

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	f67d6f73-88d7-2031-e053-2995a90a3b09	5
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	f67d6f73-88d7-2031-e053-2995a90a3b09	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51655-084-26	51655008426	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-084-26)	2023-03-06	No	No	Current
51655-084-52	51655008452	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-084-52)	2023-03-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	5