AMITRIPTYLINE HYDROCHLORIDE

Product NDC: 70518-2570
11-digit product format: 705182570
Labeler code: 70518
Product ID: 70518-2570_ca644b36-6fe9-4fa1-e053-2995a90af0b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: AMITRIPTYLINE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA202446
Marketing category: ANDA
Marketing start: 2020-02-06
Marketing end: 0000-00-00
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 75 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70518-2570		D	Discontinued by firm		2026-10-05
excluded package	package	70518-2570	70518-2570-0	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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-2570-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-2570-0	`f5e01cc5f278…`	`a2eaf40c39c3…`

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2570-0	2023-03-10	C162847	48780-1	f386c64a-3c4b-0266-e053-dadaa90a7c1a	Amitriptyline Hydrochloride Tablets, USP
70518-2570-0	2023-01-30	C162847	48780-1	f386c64a-3c4b-0266-e053-dadaa90a7c1a	Amitriptyline Hydrochloride Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-2570-0	EA - Each	70518-2570	2389bc1c-0d34-4460-a4b4-263e710435e4	1	2023-01-09

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2570-0	70518257000	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2570-0)	2020-02-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP	REMEDYREPACK INC.	2024-03-01	HUMAN PRESCRIPTION DRUG LABEL	4