Chlordiazepoxide Hydrochloride

Product NDC: 43063-046
11-digit product format: 430630046
Labeler code: 43063
Product ID: 43063-046_3edd1001-c580-bf18-e063-6394a90a3c31
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlordiazepoxide Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA084769
Marketing category: ANDA
Marketing start: 1976-07-01
Substance: CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength: 25 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 1.

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
A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RLD, RS, 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
A084769-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084769-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE / ORAL	AB	Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084769-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084769-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084769-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084769-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084769-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084769-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084769-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084769-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084769-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084769-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084769-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084769-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084769-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084769-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084769-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084769-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084769-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084769-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084769-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084769-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084769-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084769-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084769-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084769-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084769-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084769-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084769-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084769-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084769-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084769-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084769-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084769-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084769-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084769-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084769-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084769-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084769-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084769-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084769-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084769-001	AB	1	`cb3db0bc1861…`

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	25 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905495	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
3cbd7cee-c4d7-4c95-93d8-09428169b937	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
6f1277d7-db3a-63fa-be84-d390d1482706	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43063-046-03	Chlordiazepoxide Hydrochloride	3 in 1 BOTTLE, PLASTIC	CAPSULE	3	19
43063-046-06	Chlordiazepoxide Hydrochloride	6 in 1 BOTTLE, PLASTIC	CAPSULE	6	19
43063-046-12	Chlordiazepoxide Hydrochloride	12 in 1 BOTTLE, PLASTIC	CAPSULE	12	19
43063-046-15	Chlordiazepoxide Hydrochloride	15 in 1 BOTTLE, PLASTIC	CAPSULE	15	19
43063-046-19	Chlordiazepoxide Hydrochloride	19 in 1 BOTTLE, PLASTIC	CAPSULE	19	19
43063-046-24	Chlordiazepoxide Hydrochloride	24 in 1 BOTTLE, PLASTIC	CAPSULE	24	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-046-03	EA - Each	43063-046	ccfcf470-c38b-43c4-9a67-ad829973ba0d	1	2012-07-24
43063-046-06	EA - Each	43063-046	79a016b8-1448-4ef9-8923-4cad8eb3405d	1	2012-07-24
43063-046-12	EA - Each	43063-046	bed3c61c-5bf8-4fd6-89fb-b406a702c472	1	2012-07-24
43063-046-15	EA - Each	43063-046	4599f917-44cb-4c73-8a85-da339b391205	1	2012-07-24
43063-046-19	EA - Each	43063-046	6a171e4f-3297-4562-b40c-9375fece5ae8	1	2012-07-24
43063-046-24	EA - Each	43063-046	daf5cd85-066c-4666-ab3c-435012c97b35	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLORDIAZEPOXIDE HYDROCHLORIDE	ACTIVE INGREDIENT	MFM6K1XWDK	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
CHLORDIAZEPOXIDE	ACTIVE MOIETY	6RZ6XEZ3CR	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43063-046	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]	18	Current NDC, Legacy NDC, 6 package rows	20240922_3cbd7cee-c4d7-4c95-93d8-09428169b937.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	REMEDYREPACK INC.	43daab7a-3809-4b13-b015-4806912c3c4a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084769 application number: ANDA084769
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Unit Dose Solutions, Inc.	53c278b6-d22d-79bd-e063-6294a90a82cd	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084769 application number: ANDA084769
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Couper LLC	511264f5-024b-350a-e063-6394a90a51e9	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084769 application number: ANDA084769
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): 084769 application number: ANDA084769
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	REMEDYREPACK INC.	cba55889-e81e-404d-974b-4af484eccfb1	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084769 application number: ANDA084769
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): 084769 application number: ANDA084769
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	PD-Rx Pharmaceuticals, Inc.	3cbd7cee-c4d7-4c95-93d8-09428169b937	2025-09-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084769 application number: ANDA084769 ndc (product): 43063-046
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	American Health Packaging	1eb5eb7a-8c5f-43a3-9b9f-6321cdb6f6c7	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084769 application number: ANDA084769
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): 084769 application number: ANDA084769
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	a57a5046-f73b-10a9-e053-2a95a90ad72f	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084769 application number: ANDA084769
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9e64d2d8-b12c-5639-e053-2a95a90aab80	2024-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084769 application number: ANDA084769
Chlordiazepoxide Hydrochloride	CHLORDIAZEPOXIDE HYDROCHLORIDE	Clinical Solutions Wholesale, LLC	3d4cab96-8a67-4d26-a9cc-b1a02fb6c146	2024-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084769 application number: ANDA084769

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
905495	chlordiazePOXIDE HCl 25 MG Oral Capsule	PSN	3cbd7cee-c4d7-4c95-93d8-09428169b937	19
905495	chlordiazepoxide hydrochloride 25 MG Oral Capsule	SCD	3cbd7cee-c4d7-4c95-93d8-09428169b937	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-046-03	43063004603	3 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-03)	3 capsule	2010-12-06	0000-00-00	No	No	Current
43063-046-06	43063004606	6 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-06)	6 capsule	2010-12-06	0000-00-00	No	No	Current
43063-046-12	43063004612	12 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-12)	12 capsule	2010-12-06	0000-00-00	No	No	Current
43063-046-15	43063004615	15 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-15)	15 capsule	2010-12-06	0000-00-00	No	No	Current
43063-046-19	43063004619	19 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-19)	19 capsule	2010-12-06	0000-00-00	No	No	Current
43063-046-24	43063004624	24 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-24)	24 capsule	2010-12-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlordiazepoxide Hydrochloride Capsules, USP CIV Rx only	PD-Rx Pharmaceuticals, Inc.	2025-09-15	HUMAN PRESCRIPTION DRUG LABEL	19