Chlordiazepoxide Hydrochloride

Product NDC
70518-0157
11-digit product format
705180157
Labeler code
70518
Product ID
70518-0157_4cd7ce03-886c-591f-e063-6394a90ac526
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA084769
Marketing category
ANDA
Marketing start
2017-01-19
Substance
CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength
25 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

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-015770518-0157-1DDiscontinued by firm2026-08-03
excluded packagepackage70518-015770518-0157-2DDiscontinued by firm2026-08-03

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 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-0157-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-0157-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-0157-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-0157-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-0157-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-0157-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-0157-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-0157-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-0157-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-0157-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-0157-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-0157-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-0157-1367a005e9d99…383a685ebd0f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A084769-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABApproved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A084769-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084769-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A084769-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084769-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084769-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084769-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084769-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084769-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084769-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084769-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084769-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084769-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084769-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084769-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084769-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084769-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084769-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084769-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084769-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084769-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084769-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A084769-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084769-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084769-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084769-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A084769-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A084769-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084769-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084769-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084769-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084769-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084769-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084769-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084769-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A084769-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A084769-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084769-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084769-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084769-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084769-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORDIAZEPOXIDE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MFM6K1XWDKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
905495Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
43daab7a-3809-4b13-b015-4806912c3c4aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
632cace7-5e66-44d3-b8c3-9d6af8cdd96aProduct name520250623
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0157-0Chlordiazepoxide Hydrochloride30 in 1 BLISTER PACKCAPSULE3019
70518-0157-1Chlordiazepoxide Hydrochloride100 in 1 BOTTLE, PLASTICCAPSULE10019
70518-0157-2Chlordiazepoxide Hydrochloride100 in 1 BOTTLECAPSULE10019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0157CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 3 package rows20250529_43daab7a-3809-4b13-b015-4806912c3c4a.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEREMEDYREPACK INC.43daab7a-3809-4b13-b015-4806912c3c4a2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
ndc (product): 70518-0157
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEUnit Dose Solutions, Inc.53c278b6-d22d-79bd-e063-6294a90a82cd2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDECouper LLC511264f5-024b-350a-e063-6394a90a51e92026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDESafecor Health, LLC60abf20f-0c6c-43b9-8b55-f4957e2a655d2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEREMEDYREPACK INC.cba55889-e81e-404d-974b-4af484eccfb12026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEMylan Institutional Inc.68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a2025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3cbd7cee-c4d7-4c95-93d8-09428169b9372025-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEAmerican Health Packaging1eb5eb7a-8c5f-43a3-9b9f-6321cdb6f6c72025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.e3ff8641-ae8a-4016-acb1-cb1b7890f5ed2025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a57a5046-f73b-10a9-e053-2a95a90ad72f2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.9e64d2d8-b12c-5639-e053-2a95a90aab802024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEClinical Solutions Wholesale, LLC3d4cab96-8a67-4d26-a9cc-b1a02fb6c1462024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905495chlordiazePOXIDE HCl 25 MG Oral CapsulePSN43daab7a-3809-4b13-b015-4806912c3c4a19
905495chlordiazepoxide hydrochloride 25 MG Oral CapsuleSCD43daab7a-3809-4b13-b015-4806912c3c4a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-0157-07051801570030 CAPSULE in 1 BLISTER PACK (70518-0157-0) 30 capsule2017-01-19NoNoCurrent
70518-0157-170518015701100 in 1 BOTTLE, PLASTICHistorical
70518-0157-270518015702100 in 1 BOTTLEHistorical