AMITRIPTYLINE HYDROCHLORIDE

Product NDC: 63629-1369
11-digit product format: 636291369
Labeler code: 63629
Product ID: 63629-1369_8d720a85-1135-4a34-9e56-381b39c28fb9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
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: No
Listing certified through: 2021-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-1369		D	Discontinued by firm	2026-10-15
excluded package	package	63629-1369	63629-1369-0	D	Discontinued by firm	2026-10-15
excluded package	package	63629-1369	63629-1369-1	D	Discontinued by firm	2026-10-15
excluded package	package	63629-1369	63629-1369-2	D	Discontinued by firm	2026-10-15
excluded package	package	63629-1369	63629-1369-3	D	Discontinued by firm	2026-10-15
excluded package	package	63629-1369	63629-1369-4	D	Discontinued by firm	2026-10-15
excluded package	package	63629-1369	63629-1369-5	D	Discontinued by firm	2026-10-15
excluded package	package	63629-1369	63629-1369-6	D	Discontinued by firm	2026-10-15
excluded package	package	63629-1369	63629-1369-7	D	Discontinued by firm	2026-10-15
excluded package	package	63629-1369	63629-1369-8	D	Discontinued by firm	2026-10-15
excluded package	package	63629-1369	63629-1369-9	D	Discontinued by firm	2026-10-15

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 3 · 165 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	63629-1369-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1369-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1369-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1369-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1369-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1369-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1369-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1369-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1369-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-1369-7	`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	63629-1369-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1369-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1369-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1369-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1369-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1369-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1369-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1369-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1369-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-1369-7	`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	63629-1369-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1369-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1369-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1369-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1369-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1369-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1369-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1369-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1369-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-1369-7	`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	63629-1369-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1369-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1369-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1369-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1369-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1369-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1369-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1369-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1369-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-1369-7	`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	63629-1369-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1369-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1369-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1369-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1369-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1369-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1369-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1369-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1369-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-1369-7	`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	63629-1369-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1369-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1369-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-1369-6	`cdf11ea48f46…`	`ba0047e9e063…`

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-1369-0	2021-01-06	Amitriptyline Hydrochloride Tablets, USP
63629-1369-1	2021-01-06	Amitriptyline Hydrochloride Tablets, USP
63629-1369-2	2021-01-06	Amitriptyline Hydrochloride Tablets, USP
63629-1369-3	2021-01-06	Amitriptyline Hydrochloride Tablets, USP
63629-1369-4	2021-01-06	Amitriptyline Hydrochloride Tablets, USP
63629-1369-5	2021-01-06	Amitriptyline Hydrochloride Tablets, USP
63629-1369-6	2021-01-06	Amitriptyline Hydrochloride Tablets, USP
63629-1369-7	2021-01-06	Amitriptyline Hydrochloride Tablets, USP
63629-1369-8	2021-01-06	Amitriptyline Hydrochloride Tablets, USP
63629-1369-9	2021-01-06	Amitriptyline Hydrochloride Tablets, USP
63629-1369-0	2019-11-27	Amitriptyline Hydrochloride Tablets, USP
63629-1369-1	2019-11-27	Amitriptyline Hydrochloride Tablets, USP
63629-1369-2	2019-11-27	Amitriptyline Hydrochloride Tablets, USP
63629-1369-3	2019-11-27	Amitriptyline Hydrochloride Tablets, USP
63629-1369-4	2019-11-27	Amitriptyline Hydrochloride Tablets, USP
63629-1369-5	2019-11-27	Amitriptyline Hydrochloride Tablets, USP
63629-1369-6	2019-11-27	Amitriptyline Hydrochloride Tablets, USP
63629-1369-7	2019-11-27	Amitriptyline Hydrochloride Tablets, USP
63629-1369-8	2019-11-27	Amitriptyline Hydrochloride Tablets, USP
63629-1369-9	2019-11-27	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
63629-1369-1	EA - Each	63629-1369	f8ea5358-a9d2-4cc2-9a9f-8ab6c54063d8	1	2012-07-24
63629-1369-2	EA - Each	63629-1369	ca6602e9-c962-474f-8aa5-7f632c3d3588	1	2012-07-24
63629-1369-3	EA - Each	63629-1369	1b6b8598-50a3-4314-bec0-f164d287a10b	1	2012-07-24
63629-1369-4	EA - Each	63629-1369	890b5668-3049-40b6-ab47-495dd34cd5ba	1	2012-07-24
63629-1369-5	EA - Each	63629-1369	c63892cc-0903-4de1-b24f-0d0aa3da1717	1	2012-07-24
63629-1369-6	EA - Each	63629-1369	e15ff982-5476-436f-9006-382ebf7adb1f	1	2012-07-24
63629-1369-7	EA - Each	63629-1369	f7abe0eb-a853-44fc-ac97-ccb55b5a537d	1	2012-07-24
63629-1369-8	EA - Each	63629-1369	a36c363e-426a-49d3-8cbe-a4a8de9c6b96	1	2012-07-24
63629-1369-9	EA - Each	63629-1369	30e674bd-aa12-4e4e-964e-f54f881e2c4d	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 (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE ) TABLET [BRYANT RANCH PREPACK]	2

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
63629-1369-0	63629136900	120 TABLET, FILM COATED in 1 BOTTLE (63629-1369-0)	1977-11-21	0000-00-00	No	No	Current
63629-1369-1	63629136901	20 TABLET, FILM COATED in 1 BOTTLE (63629-1369-1)	1977-11-21	0000-00-00	No	No	Current
63629-1369-2	63629136902	30 TABLET, FILM COATED in 1 BOTTLE (63629-1369-2)	1977-11-21	0000-00-00	No	No	Current
63629-1369-3	63629136903	100 TABLET, FILM COATED in 1 BOTTLE (63629-1369-3)	1977-11-21	0000-00-00	No	No	Current
63629-1369-4	63629136904	60 TABLET, FILM COATED in 1 BOTTLE (63629-1369-4)	1977-11-21	0000-00-00	No	No	Current
63629-1369-5	63629136905	50 TABLET, FILM COATED in 1 BOTTLE (63629-1369-5)	1977-11-21	0000-00-00	No	No	Current
63629-1369-6	63629136906	90 TABLET, FILM COATED in 1 BOTTLE (63629-1369-6)	1977-11-21	0000-00-00	No	No	Current
63629-1369-7	63629136907	45 TABLET, FILM COATED in 1 BOTTLE (63629-1369-7)	1977-11-21	0000-00-00	No	No	Current
63629-1369-8	63629136908	28 TABLET, FILM COATED in 1 BOTTLE (63629-1369-8)	1977-11-21	0000-00-00	No	No	Current
63629-1369-9	63629136909	56 TABLET, FILM COATED in 1 BOTTLE (63629-1369-9)	1977-11-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP	Bryant Ranch Prepack	2020-10-12	HUMAN PRESCRIPTION DRUG LABEL	4