Home NDC 0378-0070-01 Clorazepate Dipotassium
Product NDC 0378-0070
Requested package NDC 0378-0070-01
11-digit product format 003780070
Labeler code 0378
Product ID 0378-0070_21627ba9-f1e6-4251-b3fc-8836c1f7266f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clorazepate dipotassium
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA071858
Marketing category ANDA
Marketing start 1987-07-17
Marketing end 0000-00-00
Substance CLORAZEPATE DIPOTASSIUM
Active strength 15 mg/1
Pharmacologic classes Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule CIV
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 12 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 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…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 A071858-001 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 A071858-002 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 A071858-003 CLORAZEPATE DIPOTASSIUM CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17
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 4 · 123 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 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071858-002 CLORAZEPATE DIPOTASSIUM 3.75MG TABLET / ORAL AB 1987-07-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071858-003 CLORAZEPATE DIPOTASSIUM 7.5MG TABLET / ORAL AB 1987-07-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071858-001 CLORAZEPATE DIPOTASSIUM 15MG TABLET / ORAL AB RS 1987-07-17 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CLORAZEPATE DIPOTASSIUM ACTIVE INGREDIENT 63FN7G03XY CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.] 5 CLORAZEPATE DIPOTASSIUM ACTIVE INGREDIENT 63FN7G03XY CLORAZEPATE DIPOTASSIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 CLORAZEPIC ACID ACTIVE MOIETY D51WO0G0L4 CLORAZEPATE DIPOTASSIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 CLORAZEPIC ACID ACTIVE MOIETY D51WO0G0L4 CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.] 5 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U CLORAZEPATE DIPOTASSIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CLORAZEPATE DIPOTASSIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.] 5 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.] 5 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.] 5 MAGNESIUM OXIDE INACTIVE INGREDIENT 3A3U0GI71G CLORAZEPATE DIPOTASSIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 MAGNESIUM OXIDE INACTIVE INGREDIENT 3A3U0GI71G CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.] 5 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CLORAZEPATE DIPOTASSIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 POTASSIUM CARBONATE INACTIVE INGREDIENT BQN1B9B9HA CLORAZEPATE DIPOTASSIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 POTASSIUM CARBONATE INACTIVE INGREDIENT BQN1B9B9HA CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.] 5 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CLORAZEPATE DIPOTASSIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CLORAZEPATE DIPOTASSIUM TABLET [PD-RX PHARMACEUTICALS, INC.] 5 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CLORAZEPATE DIPOTASSIUM TABLET [MYLAN PHARMACEUTICALS INC.] 5
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-0070-01 00378007001 100 TABLET in 1 BOTTLE, PLASTIC (0378-0070-01) 100 tablet 1987-07-17 0000-00-00 No No Current