Home NDC 60505-4754 Clorazepate Dipotassium
Product NDC 60505-4754
11-digit product format 605054754
Labeler code 60505
Product ID 60505-4754_ab0eda3d-5823-2483-7ecc-aa22d0a9e25f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clorazepate Dipotassium
Dosage form TABLET
Route ORAL
Labeler Apotex Corp.
Application ANDA215566
Marketing category ANDA
Marketing start 2022-09-22
Substance CLORAZEPATE DIPOTASSIUM
Active strength 3.75 mg/mg
Pharmacologic classes Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215566-001 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 A215566-002 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 A215566-003 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 3 · 87 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215566-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215566-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-06-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215566-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-14 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 87 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Clorazepate Dipotassium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLORAZEPATE DIPOTASSIUM 3.75 mg/mg
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 63FN7G03XY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197464 Internal RxNorm lookup 197465 Internal RxNorm lookup 197466 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4754-1 Clorazepate Dipotassium 100 mg in 1 BOTTLE TABLET 100 4 60505-4754-3 Clorazepate Dipotassium 30 mg in 1 BOTTLE TABLET 30 4 60505-4754-5 Clorazepate Dipotassium 500 mg in 1 BOTTLE TABLET 500 4 60505-4754-7 Clorazepate Dipotassium 1000 mg in 1 BOTTLE TABLET 1000 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-4754 CLORAZEPATE DIPOTASSIUM TABLET [APOTEX CORP.] 3 Current NDC, Legacy NDC, 4 package rows 20240925_6e07efe5-29b6-6d1e-661a-f696c4b17f43.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 60505-4754-1 60505475401 100 mg in 1 BOTTLE (60505-4754-1) 100 mg 2022-09-22 0000-00-00 No No Current 60505-4754-3 60505475403 30 mg in 1 BOTTLE 30 mg Historical 60505-4754-5 60505475405 500 mg in 1 BOTTLE 500 mg Historical 60505-4754-7 60505475407 1000 mg in 1 BOTTLE 1000 mg Historical