Chlordiazepoxide Hydrochloride

Product NDC
63629-4669
Requested package NDC
63629-4669-2
11-digit product format
636294669
Labeler code
63629
Product ID
63629-4669_041c8d6d-7f4a-4a89-a086-622002e425d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA083116
Marketing category
ANDA
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength
10 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-466963629-4669-2DDiscontinued by firm2026-08-17

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, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05IInactivated by FDA110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABRLD, 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
A083116-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABRLD, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A083116-001CHLORDIAZEPOXIDE HYDROCHLORIDE10MGCAPSULE / ORALABApproved before 1982e64feba35796…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A083116-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A083116-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A083116-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A083116-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A083116-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A083116-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A083116-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A083116-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A083116-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A083116-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A083116-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A083116-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A083116-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A083116-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A083116-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A083116-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A083116-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A083116-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A083116-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A083116-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A083116-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A083116-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A083116-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A083116-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A083116-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A083116-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A083116-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A083116-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A083116-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A083116-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A083116-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A083116-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A083116-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A083116-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A083116-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A083116-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A083116-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A083116-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A083116-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A083116-001AB1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORDIAZEPOXIDE HYDROCHLORIDEACTIVE INGREDIENTMFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
CHLORDIAZEPOXIDEACTIVE MOIETY6RZ6XEZ3CRCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
GELATININACTIVE INGREDIENT2G86QN327LCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
SHELLACINACTIVE INGREDIENT46N107B71OCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]1001

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEREMEDYREPACK INC.9aba3135-00ff-47ba-b926-55eb16b361bf2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083116
application number: ANDA083116
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDECoupler LLC54d76424-7fab-c000-e063-6294a90af43e2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083116
application number: ANDA083116
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDESafecor Health, LLC60abf20f-0c6c-43b9-8b55-f4957e2a655d2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083116
application number: ANDA083116
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEMylan Institutional Inc.68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a2025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083116
application number: ANDA083116
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.e3ff8641-ae8a-4016-acb1-cb1b7890f5ed2025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083116
application number: ANDA083116
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEClinical Solutions Wholesale, LLC74c4320d-c90d-436b-97da-07496ba88aed2024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083116
application number: ANDA083116

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4669-26362946690290 CAPSULE in 1 BOTTLE (63629-4669-2) 90 capsule2013-09-270000-00-00NoNoCurrent