Amitriptyline Hydrochloride

Product NDC: 51655-334
Requested package NDC: 51655-334-26
11-digit product format: 516550334
Labeler code: 51655
Product ID: 51655-334_4b07eec5-6946-e89e-e063-6394a90ac6ed
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: 2023-03-24
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 50 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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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 ndc (package): 51655-334-26 ndc (product): 51655-334 ndc11 (package): 51655033426
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

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	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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856845	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
f8236cd1-1b60-4a66-e053-6294a90afeb0	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
51655-334-26	Amitriptyline Hydrochloride	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-334	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]	1	Current NDC, 1 package rows	20230413_f8236cd1-1b60-4a66-e053-6294a90afeb0.zip

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	f8236cd1-1b60-4a66-e053-6294a90afeb0	4
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	f8236cd1-1b60-4a66-e053-6294a90afeb0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
51655-334-26	51655033426	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-334-26)	2023-03-24	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	4