Chlordiazepoxide Hydrochloride

Product NDC: 70518-1752
Requested package NDC: 70518-1752-1
11-digit product format: 705181752
Labeler code: 70518
Product ID: 70518-1752_49651fec-b19d-b9cb-e063-6394a90a83fd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Chlordiazepoxide Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA083116
Marketing category: ANDA
Marketing start: 2018-12-27
Substance: CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Benzodiazepine [EPC], Benzodiazepines [CS]
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 · 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 · 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083116-001	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG	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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A083116-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905369	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
9aba3135-00ff-47ba-b926-55eb16b361bf	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	Strength	SPL version
70518-1752-0	Chlordiazepoxide Hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30		13
70518-1752-1	Chlordiazepoxide Hydrochloride	30 in 1 BLISTER PACK	CAPSULE	30		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-1752-1	EA - Each	70518-1752	f44a824b-e519-4c1b-a6c8-6b4cb781abce	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-1752	CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]	9	Current NDC, Legacy NDC, 2 package rows	20250228_9aba3135-00ff-47ba-b926-55eb16b361bf.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 ndc (package): 70518-1752-1 ndc (product): 70518-1752 ndc11 (package): 70518175201
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
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	9aba3135-00ff-47ba-b926-55eb16b361bf	13
905369	chlordiazepoxide hydrochloride 10 MG Oral Capsule	SCD	9aba3135-00ff-47ba-b926-55eb16b361bf	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-1752-1	70518175201	30 CAPSULE in 1 BLISTER PACK (70518-1752-1)	30 capsule	2021-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Chlordiazepoxide Hydrochloride Capsules, USP CIV Rx only	REMEDYREPACK INC.	2026-07-10	HUMAN PRESCRIPTION DRUG LABEL	14