Amitriptyline Hydrochloride

Product NDC: 71335-1256
11-digit product format: 713351256
Labeler code: 71335
Product ID: 71335-1256_0f092778-43f5-15d0-e063-6394a90a1215
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
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

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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71335-1256		D	Discontinued by firm	2026-08-11
excluded package	package	71335-1256	71335-1256-1	D	Discontinued by firm	2026-08-11
excluded package	package	71335-1256	71335-1256-2	D	Discontinued by firm	2026-08-11
excluded package	package	71335-1256	71335-1256-3	D	Discontinued by firm	2026-08-11
excluded package	package	71335-1256	71335-1256-4	D	Discontinued by firm	2026-08-11
excluded package	package	71335-1256	71335-1256-5	D	Discontinued by firm	2026-08-11
excluded package	package	71335-1256	71335-1256-6	D	Discontinued by firm	2026-08-11
excluded package	package	71335-1256	71335-1256-7	D	Discontinued by firm	2026-08-11
excluded package	package	71335-1256	71335-1256-8	D	Discontinued by firm	2026-08-11

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 2 · 108 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	71335-1256-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1256-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1256-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1256-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1256-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1256-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1256-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71335-1256-8	`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	71335-1256-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1256-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1256-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1256-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1256-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1256-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1256-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71335-1256-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1256-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1256-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1256-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1256-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1256-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1256-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1256-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71335-1256-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1256-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1256-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1256-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1256-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1256-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1256-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1256-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71335-1256-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1256-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1256-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1256-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1256-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1256-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1256-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1256-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71335-1256-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1256-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1256-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1256-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1256-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1256-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1256-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1256-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71335-1256-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1256-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1256-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1256-2	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1256-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71335-1256-3	`302b2466d912…`	`e7b80fea0513…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856845	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
dcdeb999-412e-475f-a21d-2e0ac42d136e	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
71335-1256-1	Amitriptyline Hydrochloride	100 in 1 BOTTLE	TABLET, FILM COATED	100	101
71335-1256-2	Amitriptyline Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30	101
71335-1256-3	Amitriptyline Hydrochloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	101
71335-1256-4	Amitriptyline Hydrochloride	90 in 1 BOTTLE	TABLET, FILM COATED	90	101
71335-1256-5	Amitriptyline Hydrochloride	20 in 1 BOTTLE	TABLET, FILM COATED	20	101
71335-1256-6	Amitriptyline Hydrochloride	28 in 1 BOTTLE	TABLET, FILM COATED	28	101
71335-1256-7	Amitriptyline Hydrochloride	56 in 1 BOTTLE	TABLET, FILM COATED	56	101
71335-1256-8	Amitriptyline Hydrochloride	180 in 1 BOTTLE	TABLET, FILM COATED	180	101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1256-2	EA - Each	71335-1256	8096fbd9-130d-4530-bc50-b3c95a31301e	1	2019-09-05
71335-1256-3	EA - Each	71335-1256	4c956f9f-bbd3-4820-8a6c-09a7505e8462	1	2019-09-05
71335-1256-4	EA - Each	71335-1256	66163a15-f786-43af-8a69-15316eab0bc9	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1256	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]	101	Current NDC, Legacy NDC, 8 package rows	20240117_dcdeb999-412e-475f-a21d-2e0ac42d136e.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
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 ndc (product): 71335-1256
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1256-1	71335125601	100 TABLET, FILM COATED in 1 BOTTLE (71335-1256-1)	2022-02-09	0000-00-00	No	No	Current
71335-1256-2	71335125602	30 TABLET, FILM COATED in 1 BOTTLE (71335-1256-2)	2022-02-09	0000-00-00	No	No	Current
71335-1256-3	71335125603	60 TABLET, FILM COATED in 1 BOTTLE (71335-1256-3)	2022-02-09	0000-00-00	No	No	Current
71335-1256-4	71335125604	90 TABLET, FILM COATED in 1 BOTTLE (71335-1256-4)	2022-02-09	0000-00-00	No	No	Current
71335-1256-5	71335125605	20 TABLET, FILM COATED in 1 BOTTLE (71335-1256-5)	2022-02-09	0000-00-00	No	No	Current
71335-1256-6	71335125606	28 TABLET, FILM COATED in 1 BOTTLE (71335-1256-6)	2022-02-09	0000-00-00	No	No	Current
71335-1256-7	71335125607	56 TABLET, FILM COATED in 1 BOTTLE (71335-1256-7)	2022-02-09	0000-00-00	No	No	Current
71335-1256-8	71335125608	180 TABLET, FILM COATED in 1 BOTTLE (71335-1256-8)	2022-02-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AMITRIPTYLINE HYDROCHLORIDE TABLETS USP	Bryant Ranch Prepack	2024-01-15	HUMAN PRESCRIPTION DRUG LABEL	101