AMITRIPTYLINE HYDROCHLORIDE

Product NDC: 59651-821
11-digit product format: 596510821
Labeler code: 59651
Product ID: 59651-821_8085a37f-3c76-4f74-aab3-9a929a7eb1c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMITRIPTYLINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA086009
Marketing category: ANDA
Marketing start: 2026-03-20
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 100 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	RLD / RS
A086009-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	Approved before 1982
A086009-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	Approved before 1982
A086009-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	Approved before 1982
A086009-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	Approved before 1982
A086009-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	Approved before 1982
A086009-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086009-001	AB
A086009-002	AB
A086009-003	AB
A086009-004	AB
A086009-005	AB
A086009-006	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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086009-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086009-001	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086009-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086009-003	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086009-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A086009-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086009-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086009-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086009-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086009-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A086009-006	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086009-006	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086009-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086009-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086009-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086009-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086009-005	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A086009-006	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086009-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086009-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086009-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086009-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086009-005	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A086009-006	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086009-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086009-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086009-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086009-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086009-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A086009-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086009-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086009-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086009-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086009-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086009-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A086009-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086009-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A086009-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A086009-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A086009-004	AB	1	`b00525d2431f…`

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	100 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856762	Internal RxNorm lookup
856773	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
8085a37f-3c76-4f74-aab3-9a929a7eb1c2	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
59651-821-01	AMITRIPTYLINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100		1
59651-821-60	AMITRIPTYLINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, FILM COATED	60		1

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Aurobindo Pharma Limited	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086009 application number: ANDA086009 ndc (product): 59651-821

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
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	1
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	1
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	1
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	1
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	1
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	1
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	1
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	1
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	1
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	8085a37f-3c76-4f74-aab3-9a929a7eb1c2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
59651-821-01	59651082101	100 TABLET, FILM COATED in 1 BOTTLE (59651-821-01)	2026-03-20	No	No	Current
59651-821-60	59651082160	60 TABLET, FILM COATED in 1 BOTTLE (59651-821-60)	2026-03-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP 25 mg, 50 mg, 75 mg, 100 mg and 150 mg Rx only	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2026-04-02	Human Prescription Drug Label	1