Chlordiazepoxide Hydrochloride

Product NDC
0555-0033
11-digit product format
005550033
Labeler code
0555
Product ID
0555-0033_0e32450e-ff0c-4ab8-aeb7-34bc9fcc1962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA083116
Marketing category
ANDA
Marketing start
1990-09-30
Substance
CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength
10 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 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…

Additional Listing Data#

Finished product
Yes
Brand name base
Chlordiazepoxide Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORDIAZEPOXIDE HYDROCHLORIDE10 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
905369Internal RxNorm lookup
905495Internal RxNorm lookup
905516Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e3ff8641-ae8a-4016-acb1-cb1b7890f5edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
632cace7-5e66-44d3-b8c3-9d6af8cdd96aProduct name520250623
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-0033-02Chlordiazepoxide Hydrochloride100 in 1 BOTTLECAPSULE10016
0555-0033-05Chlordiazepoxide Hydrochloride1000 in 1 BOTTLECAPSULE100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0033-02EA - Each0555-0033f3a8db95-1094-4695-bb23-20f0dbd9e19612012-07-24
0555-0033-05EA - Each0555-0033976ce493-7e4b-4523-addd-93dd524e22b012012-07-24

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
CHLORDIAZEPOXIDE HYDROCHLORIDEACTIVE INGREDIENTMFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
CHLORDIAZEPOXIDEACTIVE MOIETY6RZ6XEZ3CRCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
GELATININACTIVE INGREDIENT2G86QN327LCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
CHLORDIAZEPOXIDE HYDROCHLORIDEACTIVE INGREDIENTMFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
CHLORDIAZEPOXIDE HYDROCHLORIDEACTIVE INGREDIENTMFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
CHLORDIAZEPOXIDEACTIVE MOIETY6RZ6XEZ3CRCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
CHLORDIAZEPOXIDEACTIVE MOIETY6RZ6XEZ3CRCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-0033CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 2 package rows20240813_e3ff8641-ae8a-4016-acb1-cb1b7890f5ed.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
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
ndc (product): 0555-0033
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEClinical Solutions Wholesale, LLC74c4320d-c90d-436b-97da-07496ba88aed2024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 083116
application number: ANDA083116

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSN68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19
905495chlordiazePOXIDE HCl 25 MG Oral CapsulePSN68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19
905516chlordiazePOXIDE HCl 5 MG Oral CapsulePSN68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCD68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19
905495chlordiazepoxide hydrochloride 25 MG Oral CapsuleSCD68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19
905516chlordiazepoxide hydrochloride 5 MG Oral CapsuleSCD68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSNe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905495chlordiazePOXIDE HCl 25 MG Oral CapsulePSNe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905516chlordiazePOXIDE HCl 5 MG Oral CapsulePSNe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCDe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905495chlordiazepoxide hydrochloride 25 MG Oral CapsuleSCDe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905516chlordiazepoxide hydrochloride 5 MG Oral CapsuleSCDe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSN9aba3135-00ff-47ba-b926-55eb16b361bf13
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCD9aba3135-00ff-47ba-b926-55eb16b361bf13
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSN74c4320d-c90d-436b-97da-07496ba88aed5
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCD74c4320d-c90d-436b-97da-07496ba88aed5
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSN82af38e7-33d7-4c68-8fa8-c753762bd60e3
905495chlordiazePOXIDE HCl 25 MG Oral CapsulePSN82af38e7-33d7-4c68-8fa8-c753762bd60e3
905516chlordiazePOXIDE HCl 5 MG Oral CapsulePSN82af38e7-33d7-4c68-8fa8-c753762bd60e3
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCD82af38e7-33d7-4c68-8fa8-c753762bd60e3
905495chlordiazepoxide hydrochloride 25 MG Oral CapsuleSCD82af38e7-33d7-4c68-8fa8-c753762bd60e3
905516chlordiazepoxide hydrochloride 5 MG Oral CapsuleSCD82af38e7-33d7-4c68-8fa8-c753762bd60e3
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSN60abf20f-0c6c-43b9-8b55-f4957e2a655d2
905495chlordiazePOXIDE HCl 25 MG Oral CapsulePSN60abf20f-0c6c-43b9-8b55-f4957e2a655d2
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCD60abf20f-0c6c-43b9-8b55-f4957e2a655d2
905495chlordiazepoxide hydrochloride 25 MG Oral CapsuleSCD60abf20f-0c6c-43b9-8b55-f4957e2a655d2
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSN5aa62277-272e-df59-e053-2a91aa0a06a71
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCD5aa62277-272e-df59-e053-2a91aa0a06a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0033-0200555003302100 CAPSULE in 1 BOTTLE (0555-0033-02) 100 capsule1990-09-300000-00-00NoNoCurrent
0555-0033-05005550033051000 CAPSULE in 1 BOTTLE (0555-0033-05) 1000 capsule1990-09-300000-00-00NoNoCurrent