Amitriptyline HCL

Product NDC: 80425-0172
11-digit product format: 804250172
Labeler code: 80425
Product ID: 80425-0172_2a99a670-af32-299d-e063-6294a90a05d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline HCL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA202446
Marketing category: ANDA
Marketing start: 2014-12-05
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 10 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 43.

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
A202446-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04
A202446-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04
A202446-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04
A202446-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04
A202446-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04
A202446-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202446-001	AB
A202446-002	AB
A202446-003	AB
A202446-004	AB
A202446-005	AB
A202446-006	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 · 258 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
2026-09-14 22:38:34	2026-08	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202446-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202446-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202446-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202446-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

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
ca66c2fc-6724-f4cd-e053-2995a90a42cf	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
80425-0172-1	Amitriptyline HCL	30 in 1 BOTTLE	TABLET, FILM COATED	30		7
80425-0172-2	Amitriptyline HCL	60 in 1 BOTTLE	TABLET, FILM COATED	60		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0172-1	EA - Each	80425-0172	11ff396d-4803-443c-80fb-f83f688ea0d1	1	2023-03-13
80425-0172-2	EA - Each	80425-0172	67b16046-92c2-43ef-8c26-b962bf70490b	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0172	AMITRIPTYLINE HCL TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	7	Current NDC, Legacy NDC, 2 package rows	20250101_ca66c2fc-6724-f4cd-e053-2995a90a42cf.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	Northwind Health Company, LLC	e3afe026-7072-0a7d-e053-2995a90a52d4	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
Amitriptyline HCL	AMITRIPTYLINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	ca66c2fc-6724-f4cd-e053-2995a90a42cf	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446 ndc (product): 80425-0172
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	58ff9a82-5de6-a1b0-e053-2991aa0a84ba	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5a5a4040-5395-54ac-e053-2991aa0aa4ab	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	9440dd10-2f0d-42a7-a037-3ab8729708f6	2023-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	df5aee40-ffa9-4cf3-ab5f-30253f43092b	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446

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	ca66c2fc-6724-f4cd-e053-2995a90a42cf	7
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	ca66c2fc-6724-f4cd-e053-2995a90a42cf	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0172-1	80425017201	30 TABLET, FILM COATED in 1 BOTTLE (80425-0172-1)	2014-12-05	0000-00-00	No	No	Current
80425-0172-2	80425017202	60 TABLET, FILM COATED in 1 BOTTLE (80425-0172-2)	2014-12-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline HCL Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	7