Chlordiazepoxide and Amitriptyline Hydrochloride

Product NDC: 0378-0277
11-digit product format: 003780277
Labeler code: 0378
Product ID: 0378-0277_20875d8f-5848-4892-a7fb-ab36b0288215
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: chlordiazepoxide and amitriptyline hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA071297
Marketing category: ANDA
Marketing start: 1986-12-10
Substance: AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
Active strength: 27.98; 10 mg/1; mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS], Tricyclic Antidepressant [EPC]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 25MG BASE;10MG	TABLET / ORAL		RS	1986-12-10
A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL			1986-12-10

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 · 82 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
2026-02-19 14:30 UTC	2026-02	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL		RS	1986-12-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL			1986-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL		RS	1986-12-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL			1986-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL		RS	1986-12-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL			1986-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL		RS	1986-12-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL			1986-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL	AB	RS	1986-12-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL	AB		1986-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071297-001	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 25MG BASE;10MG	TABLET / ORAL		RS	1986-12-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A071297-002	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	EQ 12.5MG BASE;5MG	TABLET / ORAL			1986-12-10	`782e0a99824c…`

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	A071297-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071297-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071297-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071297-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071297-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071297-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071297-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071297-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071297-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071297-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071297-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071297-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071297-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A071297-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071297-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071297-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071297-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071297-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071297-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071297-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071297-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A071297-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071297-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071297-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071297-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A071297-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071297-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A071297-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A071297-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A071297-002	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071297-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071297-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071297-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A071297-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071297-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A071297-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071297-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071297-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071297-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071297-002	AB	1	`9b2671bbb829…`

Additional Listing Data#

Finished product: Yes
Brand name base: Chlordiazepoxide and Amitriptyline Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CHLORDIAZEPOXIDE	27.98 mg/1
AMITRIPTYLINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
26LUD4JO9K	Internal UNII lookup
6RZ6XEZ3CR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
856769	Internal RxNorm lookup
856792	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
66a756f2-ac77-451c-a19a-08896d73b15c	Available on FDA.report

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
0378-0277-01	Chlordiazepoxide and Amitriptyline Hydrochloride	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		27
0378-0277-05	Chlordiazepoxide and Amitriptyline Hydrochloride	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500		27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-0277-01	EA - Each	0378-0277	3ffb4d61-376b-4a78-97ee-2b9391efe410	1	2012-07-24
0378-0277-05	EA - Each	0378-0277	2d0c8c04-32f6-4012-b790-c8e017f05496	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMITRIPTYLINE HYDROCHLORIDE	ACTIVE INGREDIENT	26LUD4JO9K	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
CHLORDIAZEPOXIDE	ACTIVE INGREDIENT	6RZ6XEZ3CR	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
AMITRIPTYLINE	ACTIVE MOIETY	1806D8D52K	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
CHLORDIAZEPOXIDE	ACTIVE MOIETY	6RZ6XEZ3CR	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-0277	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	24	Current NDC, Legacy NDC, 2 package rows	20250406_66a756f2-ac77-451c-a19a-08896d73b15c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlordiazepoxide and Amitriptyline Hydrochloride	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	Mylan Pharmaceuticals Inc.	66a756f2-ac77-451c-a19a-08896d73b15c	2026-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071297 application number: ANDA071297 ndc (product): 0378-0277

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
856792	chlordiazePOXIDE 10 MG / amitriptyline HCl 25 MG Oral Tablet	PSN	66a756f2-ac77-451c-a19a-08896d73b15c	27
856769	chlordiazePOXIDE 5 MG / amitriptyline HCl 12.5 MG Oral Tablet	PSN	66a756f2-ac77-451c-a19a-08896d73b15c	27
856769	amitriptyline hydrochloride 12.5 MG / chlordiazepoxide 5 MG Oral Tablet	SCD	66a756f2-ac77-451c-a19a-08896d73b15c	27
856792	amitriptyline hydrochloride 25 MG / chlordiazepoxide 10 MG Oral Tablet	SCD	66a756f2-ac77-451c-a19a-08896d73b15c	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-0277-01	00378027701	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0277-01)	1986-12-10	0000-00-00	No	No	Current
0378-0277-05	00378027705	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0277-05)	1986-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlordiazepoxide and Amitriptyline Hydrochloride Tablets, USP 5 mg/12.5 mg and 10 mg/25 mg Rx only	Mylan Pharmaceuticals Inc.	2026-03-15	HUMAN PRESCRIPTION DRUG LABEL	27