Amitriptyline Hydrochloride

Product NDC: 68788-8218
11-digit product format: 687888218
Labeler code: 68788
Product ID: 68788-8218_82d00754-2c99-43ed-af8b-7cfa29e8df32
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA214548
Marketing category: ANDA
Marketing start: 2022-09-08
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
A214548-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19
A214548-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19
A214548-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19
A214548-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19
A214548-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19
A214548-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214548-001	AB
A214548-002	AB
A214548-003	AB
A214548-004	AB
A214548-005	AB
A214548-006	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 5 · 198 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	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-05-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214548-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214548-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2021-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214548-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-05-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214548-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-05-19	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 198 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	A214548-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214548-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214548-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214548-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214548-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214548-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214548-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214548-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214548-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214548-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214548-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214548-004	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
5dd07852-43a5-415c-863e-1202f82b5654	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	SPL version
68788-8218-3	Amitriptyline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	5
68788-8218-6	Amitriptyline Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	5
68788-8218-9	Amitriptyline Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8218-3	EA - Each	68788-8218	c80ced6b-e51e-47f2-829c-0ff0148830ea	1	2022-09-12
68788-8218-6	EA - Each	68788-8218	0493a0a3-878f-4c65-9970-f3fd6a143157	1	2022-09-12
68788-8218-9	EA - Each	68788-8218	c51ec02a-7f71-4fda-aed9-38c01693280b	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8218	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]	4	Current NDC, Legacy NDC, 3 package rows	20250124_5dd07852-43a5-415c-863e-1202f82b5654.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 3 · 43 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	471b99ac-395c-3137-e063-6394a90af18d	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	e3dd745a-57f5-4925-e053-2995a90a43c0	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	9ced0126-d597-48fb-96d3-577333760048	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	1b2d2bb8-78c8-7e8e-e063-6294a90a2576	2026-06-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Coupler LLC	50375dab-97fe-8c84-e063-6394a90a60b2	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	abf6a3f5-0df9-4b23-995d-63b973ef80c1	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	c66e9088-4f34-4b97-971e-5272b45cfc97	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	53f4f83c-4bfd-43d6-9bb8-82c21ed2864f	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline HCL	AMITRIPTYLINE HCL	Direct_Rx	f6c88d87-66bb-2962-e053-6294a90acfbe	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline HCL	AMITRIPTYLINE HCL	Direct_Rx	f6cafc62-6aa9-ca32-e053-6394a90a2086	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	451b8742-8b3c-4335-9075-c1d8313cd3d0	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	6f0c2fd1-0e0d-4f5f-80c4-266fcee09fa8	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	8b10ac1a-cf66-4efa-9abc-498b2f8a1613	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	cf03c1a1-cbd5-47dc-a5e8-70ec32b71cb1	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	5dd07852-43a5-415c-863e-1202f82b5654	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548 ndc (product): 68788-8218
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	ba6a83c4-2993-40ca-bb8f-2d6c5c3e3e26	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Northwind Health Company, LLC	43450e62-d8c1-b39e-e063-6294a90a42ee	2026-01-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Coupler LLC	4616c2be-03a5-4279-e063-6294a90ac052	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Unichem Pharmaceuticals (USA), Inc.	9c6e0e05-b579-4fae-b768-e1a664c39bb8	2025-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	2bda8478-f5ab-440a-a8a3-61ebc5721369	2025-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214548 application number: ANDA214548

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	5dd07852-43a5-415c-863e-1202f82b5654	5
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	5dd07852-43a5-415c-863e-1202f82b5654	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8218-3	68788821803	30 TABLET, FILM COATED in 1 BOTTLE (68788-8218-3)	2022-09-08	0000-00-00	No	No	Current
68788-8218-6	68788821806	60 TABLET, FILM COATED in 1 BOTTLE (68788-8218-6)	2022-09-08	0000-00-00	No	No	Current
68788-8218-9	68788821809	90 TABLET, FILM COATED in 1 BOTTLE (68788-8218-9)	2022-09-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP Rx Only	Preferred Pharmaceuticals Inc.	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL	5