Amitriptyline Hydrochloride

Product NDC: 71335-2397
11-digit product format: 713352397
Labeler code: 71335
Product ID: 71335-2397_59d04648-11e9-482b-90e7-d31d6e8703c5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA217411
Marketing category: ANDA
Marketing start: 2023-06-10
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 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
A217411-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-05-19
A217411-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-05-19
A217411-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-05-19
A217411-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2023-05-19
A217411-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-05-19
A217411-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2023-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217411-001	AB
A217411-002	AB
A217411-003	AB
A217411-004	AB
A217411-005	AB
A217411-006	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 4 · 144 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	A217411-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217411-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217411-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217411-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2023-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217411-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217411-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2023-05-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217411-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217411-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217411-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217411-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2023-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217411-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217411-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2023-05-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217411-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217411-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217411-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217411-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2023-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217411-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217411-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2023-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2023-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-05-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2023-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217411-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217411-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217411-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217411-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2023-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217411-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-05-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217411-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2023-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2023-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2023-05-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2023-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217411-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2023-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217411-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2023-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217411-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2023-05-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217411-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2023-05-19	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 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	A217411-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217411-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217411-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217411-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217411-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217411-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217411-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217411-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217411-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217411-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217411-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217411-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217411-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217411-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217411-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217411-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217411-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217411-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217411-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217411-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217411-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217411-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217411-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217411-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217411-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217411-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217411-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217411-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217411-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217411-004	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 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
a726f82c-1018-44ee-ab1f-f5d34e6b388e	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
71335-2397-0	Amitriptyline Hydrochloride	120 in 1 BOTTLE	TABLET	120	2
71335-2397-1	Amitriptyline Hydrochloride	20 in 1 BOTTLE	TABLET	20	2
71335-2397-2	Amitriptyline Hydrochloride	30 in 1 BOTTLE	TABLET	30	2
71335-2397-3	Amitriptyline Hydrochloride	100 in 1 BOTTLE	TABLET	100	2
71335-2397-4	Amitriptyline Hydrochloride	60 in 1 BOTTLE	TABLET	60	2
71335-2397-5	Amitriptyline Hydrochloride	50 in 1 BOTTLE	TABLET	50	2
71335-2397-6	Amitriptyline Hydrochloride	90 in 1 BOTTLE	TABLET	90	2
71335-2397-7	Amitriptyline Hydrochloride	45 in 1 BOTTLE	TABLET	45	2
71335-2397-8	Amitriptyline Hydrochloride	28 in 1 BOTTLE	TABLET	28	2
71335-2397-9	Amitriptyline Hydrochloride	56 in 1 BOTTLE	TABLET	56	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2397-3	EA - Each	71335-2397	6c864c70-9e79-49cf-bac2-a2a5e5452d9c	1	2025-05-14
71335-2397-6	EA - Each	71335-2397	0cdfefb1-51da-4c84-a02d-4ef16572fe9b	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-2397	AMITRIPTYLINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]	2	Current NDC, 10 package rows	20240817_a726f82c-1018-44ee-ab1f-f5d34e6b388e.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	e0aa02a9-3e2d-44c5-a6b9-843c80102249	2026-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	bb02d7b8-8f1a-4cc4-b763-223e6894f02c	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	4132f91e-6f24-476a-9028-bab86ad0598e	2026-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	REMEDYREPACK INC.	5dc3c2d7-60a2-4754-be33-1f9401c925a4	2026-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	b2f822aa-23c0-4833-afc8-f5a611b9ad5a	2026-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	147d2f8f-842d-4f09-86b0-a66edce27778	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	54485767-d7c5-4927-ae52-08537a7a91e8	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	485b87c3-2a51-133b-e063-6294a90a95c3	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	15c2afe3-3309-4abc-87d1-f3eab8d89b20	2025-11-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	9110367c-4104-4836-8af3-649f86b0b3ea	2025-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Major Pharmaceuticals	29ec1221-04d8-4b21-822e-2779fcaae62c	2025-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	85574987-8d31-4bd0-b829-bb154ef212f5	2025-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	35a6e911-507a-ef0d-e063-6294a90a07e1	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	ST. MARY'S MEDICAL PARK PHARMACY	35a7ce7d-4a29-e3f0-e063-6294a90ad66f	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	a219a68e-7ce5-4e9d-a0de-ec76960040f6	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	19b0c015-c07f-63b7-e063-6394a90a6060	2024-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline HCL	AMITRIPTYLINE HCL	Direct_rx	227affe9-36ee-2423-e063-6394a90a58f6	2024-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	3d9292dc-49a0-46f4-9980-3e8d57121d43	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	20aff9dc-98a7-6061-e063-6394a90a2aab	2024-08-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411
Amitriptyline Hydrochloride	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	a726f82c-1018-44ee-ab1f-f5d34e6b388e	2024-08-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217411 application number: ANDA217411 ndc (product): 71335-2397

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	a726f82c-1018-44ee-ab1f-f5d34e6b388e	2
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	a726f82c-1018-44ee-ab1f-f5d34e6b388e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-2397-0	71335239700	120 TABLET in 1 BOTTLE (71335-2397-0)	120 tablet	2024-05-29	No	No	Current
71335-2397-1	71335239701	20 TABLET in 1 BOTTLE (71335-2397-1)	20 tablet	2024-05-29	No	No	Current
71335-2397-2	71335239702	30 TABLET in 1 BOTTLE (71335-2397-2)	30 tablet	2024-05-29	No	No	Current
71335-2397-3	71335239703	100 TABLET in 1 BOTTLE (71335-2397-3)	100 tablet	2024-05-29	No	No	Current
71335-2397-4	71335239704	60 TABLET in 1 BOTTLE (71335-2397-4)	60 tablet	2024-05-29	No	No	Current
71335-2397-5	71335239705	50 TABLET in 1 BOTTLE (71335-2397-5)	50 tablet	2024-05-29	No	No	Current
71335-2397-6	71335239706	90 TABLET in 1 BOTTLE (71335-2397-6)	90 tablet	2024-05-29	No	No	Current
71335-2397-7	71335239707	45 TABLET in 1 BOTTLE (71335-2397-7)	45 tablet	2024-05-29	No	No	Current
71335-2397-8	71335239708	28 TABLET in 1 BOTTLE (71335-2397-8)	28 tablet	2024-05-29	No	No	Current
71335-2397-9	71335239709	56 TABLET in 1 BOTTLE (71335-2397-9)	56 tablet	2024-05-29	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2024-08-16	HUMAN PRESCRIPTION DRUG LABEL	2