Amitriptyline Hydrochloride

Product NDC: 50090-7273
11-digit product format: 500907273
Labeler code: 50090
Product ID: 50090-7273_843b6456-b3c0-4521-8e65-463fef640e30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA212654
Marketing category: ANDA
Marketing start: 2024-05-20
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 25 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
A212654-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07
A212654-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29
A212654-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29
A212654-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29
A212654-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29
A212654-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212654-001	AB
A212654-002	AB
A212654-003	AB
A212654-004	AB
A212654-005	AB
A212654-006	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 · 202 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	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2021-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2021-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212654-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2020-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212654-002	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2021-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212654-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2021-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212654-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2021-09-29	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	A212654-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212654-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212654-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212654-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212654-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212654-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212654-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212654-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212654-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212654-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212654-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212654-004	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	25 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
856834	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
085baad2-d1c7-499e-b553-7477befd04d0	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
50090-7273-0	Amitriptyline Hydrochloride	90 in 1 BOTTLE	TABLET, COATED	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7273-0	EA - Each	50090-7273	7bcb34a4-170e-49be-bab9-17b3c0c6188b	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7273	AMITRIPTYLINE HYDROCHLORIDE TABLET, COATED [A-S MEDICATION SOLUTIONS]	1	Current NDC, 1 package rows	20241015_085baad2-d1c7-499e-b553-7477befd04d0.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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	St. Mary's Medical Park Pharmacy	35aa7ab3-321a-97f7-e063-6294a90a91e2	2026-06-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	16364b31-4b8b-481a-a553-e8974c0e557c	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	ce87013b-bf4a-47d1-9808-7cb8290feb23	2026-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	9d00b912-69be-4d9a-8c81-42cfc9bf6e09	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	5fe84552-9650-42e4-9870-add97b46dfe1	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	3893689b-f794-4dfd-9bd4-3fa53069e35f	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	085baad2-d1c7-499e-b553-7477befd04d0	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654 ndc (product): 50090-7273
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	ace6748d-735c-4e6e-b327-a20101fd23d4	2025-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	56379133-cd11-4dff-b511-7cdfc9a360ca	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	AiPing Pharmaceutical, Inc.	33807ee6-8443-4613-8bbe-d66f6010fc60	2025-11-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	db4d83b8-3ce7-433e-b32a-a8dc2f44b909	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	63cd768c-4ed1-47af-901a-3835919ca4d9	2025-10-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	c072c1b3-ed8a-4f1e-ba6c-580a2b2c8f58	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	61b29703-cfc2-45c7-ae24-7bf3b77e8587	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	d46ff585-7082-4a7c-a88f-2acf3be0f1d5	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212654 application number: ANDA212654

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
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	085baad2-d1c7-499e-b553-7477befd04d0	3
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	085baad2-d1c7-499e-b553-7477befd04d0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50090-7273-0	50090727300	90 TABLET, COATED in 1 BOTTLE (50090-7273-0)	2024-10-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP	A-S Medication Solutions	2025-12-17	HUMAN PRESCRIPTION DRUG LABEL	3