Amitriptyline Hydrochloride

Product NDC: 52959-348
11-digit product format: 529590348
Labeler code: 52959
Product ID: 52959-348_a90b16ab-0c90-4e42-a281-7989f2158ebe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA085966
Marketing category: ANDA
Marketing start: 1977-11-21
Marketing end: 0000-00-00
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 12 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-348		I	Inactivated by FDA	2026-10-05
excluded package	package	52959-348	52959-348-00	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-348	52959-348-05	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-348	52959-348-10	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-348	52959-348-12	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-348	52959-348-14	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-348	52959-348-15	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-348	52959-348-20	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-348	52959-348-30	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-348	52959-348-50	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-348	52959-348-60	I	Inactivated by FDA	2026-10-05
excluded package	package	52959-348	52959-348-90	I	Inactivated by FDA	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 5 · 264 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	52959-348-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-348-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-348-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-348-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-348-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-348-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-348-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-348-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-348-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-348-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-348-05	`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	52959-348-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-348-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-348-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-348-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-348-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-348-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-348-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-348-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-348-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-348-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-348-05	`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	52959-348-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-348-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-348-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-348-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-348-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-348-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-348-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-348-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-348-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-348-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-348-05	`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	52959-348-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-348-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-348-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-348-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-348-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-348-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-348-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-348-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-348-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-348-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-348-05	`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	52959-348-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-348-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-348-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-348-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-348-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-348-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-348-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-348-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-348-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-348-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-348-05	`cfe11265f3b6…`	`090c488252e2…`

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A085966-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A085966-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085966-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085966-001	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	AB	RS, Approved before 1982	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A085966-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A085966-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A085966-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A085966-001	AB	1	`ea99ee380514…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-348-00	Amitriptyline Hydrochloride Tablets, USP
52959-348-05	Amitriptyline Hydrochloride Tablets, USP
52959-348-10	Amitriptyline Hydrochloride Tablets, USP
52959-348-12	Amitriptyline Hydrochloride Tablets, USP
52959-348-14	Amitriptyline Hydrochloride Tablets, USP
52959-348-15	Amitriptyline Hydrochloride Tablets, USP
52959-348-20	Amitriptyline Hydrochloride Tablets, USP
52959-348-30	Amitriptyline Hydrochloride Tablets, USP
52959-348-50	Amitriptyline Hydrochloride Tablets, USP
52959-348-60	Amitriptyline Hydrochloride Tablets, USP
52959-348-90	Amitriptyline Hydrochloride Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-348-30	Sentravil PM-25	30 in 1 BOTTLE	TABLET	30	25 mg	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-348-00	EA - Each	52959-348	0298ae7b-5717-4099-abd2-6fdb73a830a6	1	2012-07-24
52959-348-05	EA - Each	52959-348	c4b40757-035e-4b12-8893-3401fa3f5b4c	1	2015-10-02
52959-348-10	EA - Each	52959-348	66b21fee-1ff3-4c63-9386-f95e30c5a4e7	1	2012-07-24
52959-348-12	EA - Each	52959-348	23bd6335-80bb-40e2-97ae-698477ad0b9c	1	2012-07-24
52959-348-14	EA - Each	52959-348	6f844763-a4dc-4178-903c-51fac5ca69b1	1	2012-07-24
52959-348-15	EA - Each	52959-348	e03af29a-f786-474c-af16-6fd371ee43de	1	2012-07-24
52959-348-20	EA - Each	52959-348	ff13291f-acda-45fc-a6d2-c063576e4993	1	2012-07-24
52959-348-30	EA - Each	52959-348	11366c5d-4bb7-4c94-948e-06f5202eaa62	1	2012-07-24
52959-348-50	EA - Each	52959-348	be21963e-962d-4080-ba46-444cb9bd9f87	1	2012-07-24
52959-348-60	EA - Each	52959-348	ea5f984c-31e9-4448-80ed-e793172e9b8b	1	2012-07-24
52959-348-90	EA - Each	52959-348	82042778-a8f2-455a-912a-d67b9d49414d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
CHOLINE	ACTIVE INGREDIENT	N91BDP6H0X	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
CHOLINE	ACTIVE MOIETY	N91BDP6H0X	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-348	SENTRAVIL PM-25 (AMITRIPTYLINE HYDROCHLORIDE, CHOLINE) KIT [PHYSICIAN THERAPEUTICS LLC]	3	Legacy NDC	20110812_f72a1419-0df4-4aaa-84cf-606a17cac493.zip

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
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	f72a1419-0df4-4aaa-84cf-606a17cac493	3
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	f72a1419-0df4-4aaa-84cf-606a17cac493	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-348-30	52959034830	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP	H.J. Harkins Company, Inc. \| Sandoz Inc	2011-10-11	HUMAN PRESCRIPTION DRUG LABEL	1
Sentravil PM-25	Physician Therapeutics LLC \| Sandoz Inc \| Targeted Medical Pharma Inc. \| H.J. Harkins Company, Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	3