Protriptyline Hydrochloride

Product NDC: 0054-0210
11-digit product format: 000540210
Labeler code: 0054
Product ID: 0054-0210_5e20e02b-8764-41bf-acd3-aecd03c2dfc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Protriptyline Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp.
Application: ANDA078913
Marketing category: ANDA
Marketing start: 2008-09-16
Marketing end: 0000-00-00
Substance: PROTRIPTYLINE HYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	0054-0210		D	Discontinued by firm		2026-08-17
excluded package	package	0054-0210	0054-0210-25	D	Discontinued by firm		2026-08-17

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	0054-0210-25	`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	0054-0210-25	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078913-001	PROTRIPTYLINE HYDROCHLORIDE	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL			2008-09-16
A078913-002	PROTRIPTYLINE HYDROCHLORIDE	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL			2008-09-16

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL			2008-09-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL			2008-09-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL			2008-09-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL			2008-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL			2008-09-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL			2008-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL			2008-09-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL			2008-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB		2008-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078913-001	PROTRIPTYLINE HYDROCHLORIDE	5MG	TABLET / ORAL	AB		2008-09-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078913-002	PROTRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RS	2008-09-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078913-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078913-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078913-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078913-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078913-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078913-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078913-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078913-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078913-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078913-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078913-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078913-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078913-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078913-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078913-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078913-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078913-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078913-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078913-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078913-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078913-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078913-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078913-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078913-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078913-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078913-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078913-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078913-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078913-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078913-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078913-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078913-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078913-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078913-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078913-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078913-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078913-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078913-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078913-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078913-002	AB	1	`8869cabd3fbd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
827db2a4-2747-4bc2-b3aa-fde23307b13c	Product name	2	20201013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0210-25	EA - Each	0054-0210	03b66743-c318-4191-a1a8-037db50a46c0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PROTRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	44665V00O8	PROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]	3
PROTRIPTYLINE	ACTIVE MOIETY	4NDU154T12	PROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PROTRIPTYLINE HYDROCHLORIDE TABLET [ROXANE LABORATORIES, INC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0210	PROTRIPTYLINE HYDROCHLORIDE TABLET [HIKMA PHARMACEUTICALS USA INC.]	6	Legacy NDC	20250403_700abc58-9362-4ef5-9d7a-dd3c4d364d0a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
44665V00O8	PROTRIPTYLINE HYDROCHLORIDE	1225-55-4	PROTRIPTYLINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0210-25	00054021025	100 TABLET in 1 BOTTLE (0054-0210-25)	100 tablet	2008-09-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Protriptyline Hydrochloride Tablets, USP	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2023-07-05	HUMAN PRESCRIPTION DRUG LABEL	6