AMITRIPTYLINE HYDROCHLORIDE

Product NDC: 71335-0366
Requested package NDC: 71335-0366-5
11-digit product format: 713350366
Labeler code: 71335
Product ID: 71335-0366_3e549bef-2313-4ec3-91c4-4ecaa144982f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMITRIPTYLINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202446
Marketing category: ANDA
Marketing start: 2014-12-05
Marketing end: 0000-00-00
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-0366	71335-0366-5	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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
A202446-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04
A202446-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04
A202446-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04
A202446-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04
A202446-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04
A202446-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202446-001	AB
A202446-002	AB
A202446-003	AB
A202446-004	AB
A202446-005	AB
A202446-006	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 · 258 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	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	AB	2014-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	AB	2014-06-04	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 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	A202446-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202446-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202446-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202446-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202446-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202446-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202446-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202446-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202446-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202446-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202446-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
71335-0366-1	AMITRIPTYLINE HYDROCHLORIDE	100 in 1 BOTTLE	TABLET, FILM COATED	100	22
71335-0366-2	AMITRIPTYLINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30	22
71335-0366-3	AMITRIPTYLINE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET, FILM COATED	60	22
71335-0366-4	AMITRIPTYLINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, FILM COATED	90	22
71335-0366-5	AMITRIPTYLINE HYDROCHLORIDE	20 in 1 BOTTLE	TABLET, FILM COATED	20	22
71335-0366-6	AMITRIPTYLINE HYDROCHLORIDE	28 in 1 BOTTLE	TABLET, FILM COATED	28	22
71335-0366-7	AMITRIPTYLINE HYDROCHLORIDE	56 in 1 BOTTLE	TABLET, FILM COATED	56	22
71335-0366-8	AMITRIPTYLINE HYDROCHLORIDE	180 in 1 BOTTLE	TABLET, FILM COATED	180	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0366-1	EA - Each	71335-0366	57c8edf6-a9f4-4105-9c35-a832be845b50	1	2018-02-20
71335-0366-2	EA - Each	71335-0366	7c9881e9-c62d-4657-a9c0-7707526df829	1	2018-02-20
71335-0366-3	EA - Each	71335-0366	24f3412e-e82d-4b3c-a83a-9692aa607089	1	2018-02-20
71335-0366-4	EA - Each	71335-0366	f5a0ce02-0218-47ea-9801-fc92827ba5c2	1	2018-02-20
71335-0366-5	EA - Each	71335-0366	8a847b08-1abd-41b0-98cb-86886daad362	1	2018-02-20
71335-0366-6	EA - Each	71335-0366	fc0cb5ad-582c-4204-8e37-b539a03db0f1	1	2018-02-20
71335-0366-7	EA - Each	71335-0366	74a46d52-e6a7-4176-b093-0c4071220f5b	1	2018-02-20
71335-0366-8	EA - Each	71335-0366	fc45ed17-8b15-4e04-9120-1e1c8a4e3d2d	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0366	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	22	Legacy NDC, 8 package rows	20240820_76d3f4fd-4603-4cfc-94ab-2e62c0bdae75.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 · 7 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	e3afe026-7072-0a7d-e053-2995a90a52d4	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
Amitriptyline HCL	AMITRIPTYLINE HCL	Advanced Rx Pharmacy of Tennessee, LLC	ca66c2fc-6724-f4cd-e053-2995a90a42cf	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Bryant Ranch Prepack	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	2024-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446 ndc (package): 71335-0366-5 ndc (product): 71335-0366 ndc11 (package): 71335036605
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	58ff9a82-5de6-a1b0-e053-2991aa0a84ba	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	5a5a4040-5395-54ac-e053-2991aa0aa4ab	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	A-S Medication Solutions	9440dd10-2f0d-42a7-a037-3ab8729708f6	2023-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446
AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	Proficient Rx LP	df5aee40-ffa9-4cf3-ab5f-30253f43092b	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202446 application number: ANDA202446

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	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	76d3f4fd-4603-4cfc-94ab-2e62c0bdae75	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0366-5	71335036605	20 TABLET, FILM COATED in 1 BOTTLE (71335-0366-5)	2015-02-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP	Bryant Ranch Prepack	2024-08-19	HUMAN PRESCRIPTION DRUG LABEL	22