FDA.reportPublic FDA data

Application 084769

Type
ANDA
Sponsor
BARR

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHLORDIAZEPOXIDE HYDROCHLORIDECHLORDIAZEPOXIDE HYDROCHLORIDECAPSULE;ORAL25MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A084769-001CHLORDIAZEPOXIDE HYDROCHLORIDE25MGCAPSULE / ORALABRLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A084769-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A084769-001AB1caaa826d4ba7…
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…

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 · 10 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 HYDROCHLORIDEMylan Institutional Inc.68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a2025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
ndc (product): 51079-141
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
ndc (product): 43063-046
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
ndc (product): 0555-0159
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.a57a5046-f73b-10a9-e053-2a95a90ad72f2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
ndc (product): 68071-5256
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDENuCare Pharmaceuticals,Inc.9e64d2d8-b12c-5639-e053-2a95a90aab802024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
ndc (product): 68071-5171
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEClinical Solutions Wholesale, LLC3d4cab96-8a67-4d26-a9cc-b1a02fb6c1462024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084769
application number: ANDA084769
ndc (product): 58118-1590

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 51 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-0159Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0159Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0159Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0159Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0159Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-0159Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideTeva Pharmaceuticals USA, Inc.ANDACurrent
17856-0164Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideATLANTIC BIOLOGICALS CORP.ANDACurrent
43063-046Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-046Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-046Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-046Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-046Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-046Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-046Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0328Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideA-S Medication SolutionsANDACurrent
51079-141Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideMylan Institutional Inc.ANDACurrent
51079-141Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideMylan Institutional Inc.ANDACurrent
51079-141Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideMylan Institutional Inc.ANDACurrent
51079-141Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideMylan Institutional Inc.ANDACurrent
51079-141Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideMylan Institutional Inc.ANDACurrent
53217-183Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
55154-5652Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideCardinal HealthANDACurrent
58118-1590Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-1590Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-1590Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
58118-1590Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideClinical Solutions Wholesale, LLCANDACurrent
63629-4027Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideBryant Ranch PrepackANDACurrent
63629-4027Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideBryant Ranch PrepackANDACurrent
63629-4027Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideBryant Ranch PrepackANDACurrent
64725-0159Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideTYA PharmaceuticalsANDACurrent
66267-051Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-771Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
66267-771Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideNuCare Pharmaceuticals, Inc.ANDACurrent
67046-910Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideContract Pharmacy Services-PAANDACurrent
68071-2747Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5171Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5171Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5256Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5256Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0015Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0015Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0015Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0015Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0015Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0015Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0015Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0015Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0015Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0157Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideREMEDYREPACK INC.ANDACurrent
70518-0157Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideREMEDYREPACK INC.ANDACurrent
71610-263Chlordiazepoxide HydrochlorideChlordiazepoxide HydrochlorideAphena Pharma Solutions - Tennessee, LLCANDACurrent