Chlordiazepoxide and Amitriptyline Hydrochloride

Product NDC: 42571-303
11-digit product format: 425710303
Labeler code: 42571
Product ID: 42571-303_d77bddc1-be42-7650-e053-2995a90a5095
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlordiazepoxide and Amitriptyline Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Micro Labs Limited
Application: ANDA211925
Marketing category: ANDA
Marketing start: 2022-04-01
Marketing end: 0000-00-00
Substance: AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Active strength: 10 mg/1; mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]
DEA schedule: CIV
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	42571-303		D	Discontinued by firm	2026-10-05
excluded package	package	42571-303	42571-303-01	D	Discontinued by firm	2026-10-05
excluded package	package	42571-303	42571-303-05	D	Discontinued by firm	2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL			2022-02-02
A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 25MG BASE;10MG	TABLET / ORAL			2022-02-02

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 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL		2022-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL		2022-02-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL		2022-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL		2022-02-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL		2022-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL		2022-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL		2022-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL		2022-02-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL		2022-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL		2022-02-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211925-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB	2022-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211925-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	2022-02-02	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 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	A211925-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211925-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211925-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211925-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211925-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211925-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211925-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211925-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211925-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211925-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211925-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211925-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211925-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211925-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211925-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211925-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211925-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211925-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211925-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211925-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211925-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211925-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211925-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211925-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211925-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211925-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211925-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211925-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211925-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211925-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211925-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211925-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211925-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A211925-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211925-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A211925-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211925-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211925-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211925-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211925-002	AB	1	`9b2671bbb829…`

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
632cace7-5e66-44d3-b8c3-9d6af8cdd96a	Product name	5	20250623
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42571-303-01	Chlordiazepoxide and Amitriptyline Hydrochloride	100 in 1 BOTTLE	TABLET	100		5
42571-303-05	Chlordiazepoxide and Amitriptyline Hydrochloride	500 in 1 BOTTLE	TABLET	500		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42571-303	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE (CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE) TABLET CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET [MICRO LABS LIMITED]	4	Legacy NDC, 2 package rows	20241122_b20dcdb1-50f4-4d49-a50e-be0308962f5b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
26LUD4JO9K	AMITRIPTYLINE HYDROCHLORIDE	549-18-8	AMITRIPTYLINE HYDROCHLORIDE
6RZ6XEZ3CR	CHLORDIAZEPOXIDE	58-25-3	CHLORDIAZEPOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42571-303-01	42571030301	100 TABLET in 1 BOTTLE (42571-303-01)	100 tablet	2022-04-01	0000-00-00	No	No	Current
42571-303-05	42571030305	500 TABLET in 1 BOTTLE (42571-303-05)	500 tablet	2022-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlordiazepoxide and Amitriptyline Hydrochloride Tablets, USP CIV	Micro Labs Limited \| InvaTech Pharma Solutions LLC	2025-06-11	HUMAN PRESCRIPTION DRUG LABEL	5