Chlordiazepoxide Hydrochloride

Product NDC: 68071-2747
11-digit product format: 680712747
Labeler code: 68071
Product ID: 68071-2747_e07e26c3-00ca-0e73-e053-2995a90aee80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlordiazepoxide Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA084769
Marketing category: ANDA
Marketing start: 1976-07-01
Marketing end: 0000-00-00
Substance: CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	68071-2747		I	Inactivated by FDA		2026-08-07
excluded package	package	68071-2747	68071-2747-6	I	Inactivated by FDA		2026-08-07

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 · 18 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2747-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2747-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2747-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2747-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2747-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2747-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2747-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2747-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2747-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2747-6	2025-01-30	C162847	48780-1	2cef2736-69fa-d83d-e063-dadaa90ab31f	Chlordiazepoxide Hydrochloride Capsules, USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2747-6	Chlordiazepoxide Hydrochloride	6 in 1 BOTTLE	CAPSULE	6		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2747	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20220603_e07e2911-060e-3afc-e053-2995a90af723.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
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	e07e2911-060e-3afc-e053-2995a90af723	1
905495	chlordiazepoxide hydrochloride 25 MG Oral Capsule	SCD	e07e2911-060e-3afc-e053-2995a90af723	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2747-6	68071274706	6 CAPSULE in 1 BOTTLE (68071-2747-6)	6 capsule	2022-06-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlordiazepoxide Hydrochloride Capsules, USP CIV Rx only	NuCare Pharmaceuticals,Inc.	2022-06-02	HUMAN PRESCRIPTION DRUG LABEL	1