Amitriptyline Hydrochloride

Product NDC: 57664-689
11-digit product format: 576640689
Labeler code: 57664
Product ID: 57664-689_326a1cd7-1376-8b5e-e063-6294a90a80aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA089399
Marketing category: ANDA
Marketing start: 1987-07-14
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 50 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 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
A089399-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14
A089399-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14
A089399-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14
A089399-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14
A089399-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14
A089399-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089399-001	AB
A089399-002	AB
A089399-003	AB
A089399-004	AB
A089399-005	AB
A089399-006	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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	1987-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	1987-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	1987-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1987-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	1987-07-14	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 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	A089399-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A089399-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089399-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089399-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A089399-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089399-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089399-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089399-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089399-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

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

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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856762	Internal RxNorm lookup
856773	Internal RxNorm lookup
856783	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
4e520c63-1cf6-40f6-a51c-3f9b0e181342	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
57664-689-18	Amitriptyline Hydrochloride	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000		9
57664-689-88	Amitriptyline Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-689-18	EA - Each	57664-689	1c65ab3c-b5d3-4e6d-8eb5-71682ebe6fa8	1	2018-07-03
57664-689-88	EA - Each	57664-689	4b1c754c-4fa9-4f64-a3f1-d3eee17ca986	1	2018-07-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Amitriptyline Hydrochloride	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
Amitriptyline	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
D&C Red No. 27	INACTIVE INGREDIENT	2LRS185U6K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
D&C Red No. 30	INACTIVE INGREDIENT	2S42T2808B	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
D&C Red No. 7	INACTIVE INGREDIENT	ECW0LZ41X8	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
D&C Yellow No. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
FD&C Red No. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
hydroxypropyl cellulose (type h)	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-689	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	9	Current NDC, Legacy NDC, 2 package rows	20250412_4e520c63-1cf6-40f6-a51c-3f9b0e181342.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Golden State Medical Supply, Inc.	04e1c5f8-de7e-8ce7-e063-6394a90acc57	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	4e520c63-1cf6-40f6-a51c-3f9b0e181342	2025-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399 ndc (product): 57664-689
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	541ba74a-babb-4731-a5ef-fe7c18992c0b	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	dcdeb999-412e-475f-a21d-2e0ac42d136e	2024-01-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	25832051-837b-4682-8548-5ab9a1b7cdac	2023-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4e0f3b15-3621-48a1-9f2b-b0a373920360	2023-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 089399 application number: ANDA089399

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	dcdeb999-412e-475f-a21d-2e0ac42d136e	101
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	dcdeb999-412e-475f-a21d-2e0ac42d136e	101
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	4e520c63-1cf6-40f6-a51c-3f9b0e181342	9
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	4e0f3b15-3621-48a1-9f2b-b0a373920360	7
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	4e0f3b15-3621-48a1-9f2b-b0a373920360	7
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	4e0f3b15-3621-48a1-9f2b-b0a373920360	7
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	4e0f3b15-3621-48a1-9f2b-b0a373920360	7
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	4e0f3b15-3621-48a1-9f2b-b0a373920360	7
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	4e0f3b15-3621-48a1-9f2b-b0a373920360	7
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	04e1c5f8-de7e-8ce7-e063-6394a90acc57	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-689-18	57664068918	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-689-18)	1987-07-14	0000-00-00	No	No	Current
57664-689-88	57664068988	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-689-88)	1987-07-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMITRIPTYLINE HYDROCHLORIDE TABLETS USP	Golden State Medical Supply, Inc.	2025-08-26	HUMAN PRESCRIPTION DRUG LABEL	4
AMITRIPTYLINE HYDROCHLORIDE TABLETS USP	Sun Pharmaceutical Industries, Inc. \| Frontida BioPharm Inc. \| ALKALOIDA Chemical Company Zrt.	2025-04-10	HUMAN PRESCRIPTION DRUG LABEL	9
AMITRIPTYLINE HYDROCHLORIDE TABLETS USP	Bryant Ranch Prepack	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	101
AMITRIPTYLINE HYDROCHLORIDE TABLETS USP	Aphena Pharma Solutions - Tennessee, LLC	2023-09-15	HUMAN PRESCRIPTION DRUG LABEL	7