Amitriptyline Hydrochloride

Product NDC: 0603-2215
11-digit product format: 006032215
Labeler code: 0603
Product ID: 0603-2215_a7995882-a206-47a1-af3b-c8c047aec191
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Amitriptyline Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: ANDA040218
Marketing category: ANDA
Marketing start: 1997-09-11
Marketing end: 0000-00-00
Substance: AMITRIPTYLINE HYDROCHLORIDE
Active strength: 75 mg/1
Pharmacologic classes: Tricyclic Antidepressant [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	0603-2215		D	Discontinued by firm	2026-08-11
excluded package	package	0603-2215	0603-2215-21	D	Discontinued by firm	2026-08-11
excluded package	package	0603-2215	0603-2215-25	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 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-2215-21	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0603-2215-25	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-2215-21	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0603-2215-25	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-2215-21	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0603-2215-25	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-2215-21	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0603-2215-25	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-2215-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0603-2215-25	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-2215-21	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0603-2215-25	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-2215-21	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0603-2215-25	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-2215-21	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0603-2215-25	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-2215-21	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0603-2215-25	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-2215-21	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0603-2215-25	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-2215-21	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0603-2215-25	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-2215-21	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0603-2215-25	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0603-2215-21	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`

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	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 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040218-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	1997-09-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040218-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	1997-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040218-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	1997-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040218-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	1997-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040218-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	1997-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040218-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	1997-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040218-005	AMITRIPTYLINE HYDROCHLORIDE	100MG	TABLET / ORAL	1997-09-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040218-006	AMITRIPTYLINE HYDROCHLORIDE	150MG	TABLET / ORAL	1997-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040218-001	AMITRIPTYLINE HYDROCHLORIDE	10MG	TABLET / ORAL	1997-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040218-002	AMITRIPTYLINE HYDROCHLORIDE	25MG	TABLET / ORAL	1997-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040218-003	AMITRIPTYLINE HYDROCHLORIDE	50MG	TABLET / ORAL	1997-09-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040218-004	AMITRIPTYLINE HYDROCHLORIDE	75MG	TABLET / ORAL	1997-09-11	`2680178bc6a6…`

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 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, Effective, Related label table
NDC	Effective	Related label
0603-2215-21	2022-09-28	Amitriptyline Hydrochloride Tablets, USP Rx only
0603-2215-25	2022-09-28	Amitriptyline Hydrochloride Tablets, USP Rx only
0603-2215-21	2022-07-29	Amitriptyline Hydrochloride Tablets, USP Rx only
0603-2215-25	2022-07-29	Amitriptyline Hydrochloride Tablets, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0603-2215-21	EA - Each	0603-2215	fdde608c-fe38-4fc5-b5b8-dc1c6475f150	1	2012-07-24
0603-2215-25	EA - Each	0603-2215	543a8f53-3af8-4ca9-874b-e6a822a8756a	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 [QUALITEST PHARMACEUTICALS]	19
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS]	19
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1

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
856783	amitriptyline HCl 10 MG Oral Tablet	PSN	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	c958b45e-7ca1-400a-b723-56e8c3aa98d8	1
856762	amitriptyline HCl 100 MG Oral Tablet	PSN	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856773	amitriptyline HCl 150 MG Oral Tablet	PSN	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	c958b45e-7ca1-400a-b723-56e8c3aa98d8	1
856834	amitriptyline HCl 25 MG Oral Tablet	PSN	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	c958b45e-7ca1-400a-b723-56e8c3aa98d8	1
856845	amitriptyline HCl 50 MG Oral Tablet	PSN	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	c958b45e-7ca1-400a-b723-56e8c3aa98d8	1
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	5664d192-10d8-4766-b0ba-6095d14c927d	1
856853	amitriptyline HCl 75 MG Oral Tablet	PSN	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856783	amitriptyline hydrochloride 10 MG Oral Tablet	SCD	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	c958b45e-7ca1-400a-b723-56e8c3aa98d8	1
856762	amitriptyline hydrochloride 100 MG Oral Tablet	SCD	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856773	amitriptyline hydrochloride 150 MG Oral Tablet	SCD	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856834	amitriptyline hydrochloride 25 MG Oral Tablet	SCD	c958b45e-7ca1-400a-b723-56e8c3aa98d8	1
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856845	amitriptyline hydrochloride 50 MG Oral Tablet	SCD	c958b45e-7ca1-400a-b723-56e8c3aa98d8	1
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	348f7c87-ec55-4917-8cf6-4a3b749a72c1	1
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	5664d192-10d8-4766-b0ba-6095d14c927d	1
856853	amitriptyline hydrochloride 75 MG Oral Tablet	SCD	c958b45e-7ca1-400a-b723-56e8c3aa98d8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0603-2215-21	00603221521	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-2215-21)	1997-09-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitriptyline Hydrochloride Tablets, USP Rx only	Bryant Ranch Prepack	2022-04-06	HUMAN PRESCRIPTION DRUG LABEL	101
Amitriptyline Hydrochloride Tablets, USP Rx only	Par Pharmaceutical, Inc. \| Generics Bidco II LLC d/b/a Prinston Laboratories	2019-09-19	HUMAN PRESCRIPTION DRUG LABEL	28
AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP Rx only	Aidarex Pharmaceuticals LLC	2013-11-15	HUMAN PRESCRIPTION DRUG LABEL	1
AMITRIPTYLINE HYDROCHLORIDE TABLETS, USP Rx only	Contract Pharmacy Services-PA	2011-06-01	HUMAN PRESCRIPTION DRUG LABEL	1
AMITRIPTYLINE HYDROCHLORIDE - STAT RX USA LLC	STAT RX USA LLC	2010-06-21	HUMAN PRESCRIPTION DRUG LABEL	1