Home NDC 70954-159-10 Clorazepate Dipotassium
Product NDC 70954-159
Requested package NDC 70954-159-10
11-digit product format 709540159
Labeler code 70954
Product ID 70954-159_d4edcb5d-dbe9-44c4-a0a9-d3b6aba4c22d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clorazepate Dipotassium
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA213730
Marketing category ANDA
Marketing start 2022-06-16
Substance CLORAZEPATE DIPOTASSIUM
Active strength 3.75 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 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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A213730-001 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 A213730-002 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 A213730-003 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16
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 2 · 80 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 2026-02-19 14:30 UTC 2026-02 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213730-002 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 2022-06-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213730-003 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB 2022-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213730-001 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 2022-06-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 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/1
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 70954-159-10 Clorazepate Dipotassium 100 in 1 BOTTLE TABLET 100 13 70954-159-20 Clorazepate Dipotassium 500 in 1 BOTTLE TABLET 500 13 70954-159-30 Clorazepate Dipotassium 30 in 1 BOTTLE TABLET 30 13 70954-159-40 Clorazepate Dipotassium 1 in 1 BLISTER PACK TABLET 1 13 70954-159-50 Clorazepate Dipotassium 30 in 1 BOX, UNIT-DOSE TABLET 30 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70954-159 CLORAZEPATE DIPOTASSIUM TABLET [ANI PHARMACEUTICALS, INC.] 8 Current NDC, Legacy NDC, 5 package rows 20250112_a4b80e69-b7c7-471a-8ce8-4e992808c669.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 · 2 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 70954-159-10 70954015910 100 TABLET in 1 BOTTLE (70954-159-10) 100 tablet 2022-06-16 0000-00-00 No No Current