Chlordiazepoxide Hydrochloride

Product NDC: 51079-375
11-digit product format: 510790375
Labeler code: 51079
Product ID: 51079-375_4358ac27-671d-8c3d-e063-6394a90ae79f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlordiazepoxide Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Mylan Institutional Inc.
Application: ANDA083116
Marketing category: ANDA
Marketing start: 2022-05-26
Substance: CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule: CIV
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A083116-001	AB

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 · 42 observed 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
2026-08-18 06:07:40	2026-07	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	CAPSULE / ORAL	AB	Approved before 1982	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A083116-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A083116-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A083116-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A083116-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A083116-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A083116-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A083116-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A083116-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A083116-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A083116-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A083116-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A083116-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A083116-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A083116-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A083116-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A083116-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A083116-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A083116-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A083116-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A083116-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A083116-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A083116-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A083116-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A083116-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A083116-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A083116-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A083116-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A083116-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A083116-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A083116-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A083116-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A083116-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A083116-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A083116-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A083116-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A083116-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A083116-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A083116-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A083116-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A083116-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Chlordiazepoxide Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
MFM6K1XWDK	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905369	Internal RxNorm lookup
905495	Internal RxNorm lookup
905516	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
68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a	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
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
6f1277d7-db3a-63fa-be84-d390d1482706	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51079-375-01	Chlordiazepoxide Hydrochloride	1 in 1 BLISTER PACK	CAPSULE	1		19
51079-375-20	Chlordiazepoxide Hydrochloride	100 in 1 CARTON	CAPSULE	100		19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51079-375-01	EA - Each	51079-375	107b6d94-8f02-4b3f-978e-18e61bebd3f4	1	2012-07-24
51079-375-20	EA - Each	51079-375	0a6b9110-2b88-49ee-a8ef-5071b7f3a4cd	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORDIAZEPOXIDE HYDROCHLORIDE	ACTIVE INGREDIENT	MFM6K1XWDK	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
CHLORDIAZEPOXIDE	ACTIVE MOIETY	6RZ6XEZ3CR	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
ETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	IDK7C2HS09	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CARDINAL HEALTH]	6
CHLORDIAZEPOXIDE HYDROCHLORIDE	ACTIVE INGREDIENT	MFM6K1XWDK	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
CHLORDIAZEPOXIDE	ACTIVE MOIETY	6RZ6XEZ3CR	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
ETHYLENE GLYCOL MONOETHYL ETHER	INACTIVE INGREDIENT	IDK7C2HS09	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
SODIUM PROPIONATE	INACTIVE INGREDIENT	DK6Y9P42IN	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51079-375	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]	16	Current NDC, Legacy NDC, 2 package rows	20241009_68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	REMEDYREPACK INC.	9aba3135-00ff-47ba-b926-55eb16b361bf	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Coupler LLC	54d76424-7fab-c000-e063-6294a90af43e	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Safecor Health, LLC	60abf20f-0c6c-43b9-8b55-f4957e2a655d	2026-04-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Mylan Institutional Inc.	68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116 ndc (product): 51079-375
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	e3ff8641-ae8a-4016-acb1-cb1b7890f5ed	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Clinical Solutions Wholesale, LLC	74c4320d-c90d-436b-97da-07496ba88aed	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 083116 application number: ANDA083116

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MFM6K1XWDK	CHLORDIAZEPOXIDE HYDROCHLORIDE	438-41-5	CHLORDIAZEPOXIDE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
905369	chlordiazePOXIDE HCl 10 MG Oral Capsule	PSN	68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a	19
905495	chlordiazePOXIDE HCl 25 MG Oral Capsule	PSN	68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a	19
905516	chlordiazePOXIDE HCl 5 MG Oral Capsule	PSN	68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a	19
905369	chlordiazepoxide hydrochloride 10 MG Oral Capsule	SCD	68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a	19
905495	chlordiazepoxide hydrochloride 25 MG Oral Capsule	SCD	68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a	19
905516	chlordiazepoxide hydrochloride 5 MG Oral Capsule	SCD	68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51079-375-01	51079037501	1 in 1 BLISTER PACK						Historical
51079-375-20	51079037520	100 BLISTER PACK in 1 CARTON (51079-375-20) / 1 CAPSULE in 1 BLISTER PACK (51079-375-01)	100 blister pack	2022-05-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlordiazepoxide Hydrochloride Capsules, USP CIV Rx only	Mylan Institutional Inc.	2025-11-11	HUMAN PRESCRIPTION DRUG LABEL	19
Chlordiazepoxide Hydrochloride Capsules USP CIV Rx only	Cardinal Health \| UDL Laboratories, Inc.	2018-09-11	HUMAN PRESCRIPTION DRUG LABEL	8