Amitriptyline Hydrochloride

Product NDC: 55289-124
11-digit product format: 552890124
Labeler code: 55289
Product ID: 55289-124_d2313aa0-7b6c-17cc-e053-2995a90a8cfc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA040218
Marketing category: ANDA
Marketing start: 1997-09-11
Marketing end: 0000-00-00
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 10 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55289-124		D	Discontinued by firm	2026-09-14
excluded package	package	55289-124	55289-124-12	D	Discontinued by firm	2026-09-14
excluded package	package	55289-124	55289-124-30	D	Discontinued by firm	2026-09-14

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 · 36 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	55289-124-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55289-124-30	`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	55289-124-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55289-124-30	`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	55289-124-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55289-124-30	`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	55289-124-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55289-124-30	`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	55289-124-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55289-124-30	`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	55289-124-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55289-124-30	`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	55289-124-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55289-124-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55289-124-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55289-124-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55289-124-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55289-124-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55289-124-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55289-124-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55289-124-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55289-124-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55289-124-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55289-124-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A040218-001	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	1997-09-11
A040218-002	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	1997-09-11
A040218-003	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	1997-09-11
A040218-004	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	1997-09-11
A040218-005	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	1997-09-11
A040218-006	AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	1997-09-11

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040218-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	1997-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040218-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	1997-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040218-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	1997-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040218-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	1997-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040218-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	1997-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040218-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	1997-09-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040218-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	1997-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040218-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	1997-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040218-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	1997-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040218-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	1997-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040218-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	1997-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040218-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	1997-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040218-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	1997-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040218-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	1997-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040218-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	1997-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040218-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	1997-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040218-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	1997-09-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040218-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	1997-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040218-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	1997-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040218-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	1997-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040218-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	1997-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040218-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	1997-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040218-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	1997-09-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040218-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	1997-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040218-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	1997-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040218-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	1997-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040218-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	1997-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040218-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	1997-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040218-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	1997-09-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040218-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	1997-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040218-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	1997-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040218-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	1997-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040218-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	1997-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040218-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	1997-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040218-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	1997-09-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040218-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	1997-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040218-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	1997-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040218-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	1997-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040218-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	1997-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040218-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	1997-09-11	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040218-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040218-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040218-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040218-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040218-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040218-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040218-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040218-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040218-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040218-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040218-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040218-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040218-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040218-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040218-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040218-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040218-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040218-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040218-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040218-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040218-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040218-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040218-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040218-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040218-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040218-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040218-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040218-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040218-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040218-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040218-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040218-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040218-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040218-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040218-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040218-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040218-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040218-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040218-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040218-004	AB	1	`87673890dc5c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55289-124-12	EA - Each	55289-124	0ce75624-fca1-401e-bad5-256116f40181	1	2012-07-24
55289-124-30	EA - Each	55289-124	e85d6240-aa6a-4f81-b591-faac7e44fd14	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]	9

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
55289-124-12	55289012412	12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-124-12)	2010-04-13	0000-00-00	No	No	Current
55289-124-30	55289012430	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-124-30)	2010-04-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP Rx only	PD-Rx Pharmaceuticals, Inc.	2021-12-02	HUMAN PRESCRIPTION DRUG LABEL	28