Clorazepate Dipotassium
- Product NDC
- 72603-112
- 11-digit product format
- 726030112
- Labeler code
- 72603
- Product ID
- 72603-112_258be954-8e31-2be4-e063-6394a90a78ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Clorazepate Dipotassium
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NORTHSTAR RX LLC
- Application
- ANDA075731
- Marketing category
- ANDA
- Marketing start
- 2022-10-24
- 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075731-001 | CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | |
| A075731-002 | CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | |
| A075731-003 | CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075731-001 | AB |
| A075731-002 | AB |
| A075731-003 | AB |
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.
| 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 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075731-002 | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET / ORAL | AB | 2000-04-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075731-003 | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET / ORAL | AB | 2000-04-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075731-001 | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET / ORAL | AB | 2000-04-27 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075731-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075731-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075731-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075731-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075731-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075731-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075731-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075731-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075731-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075731-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075731-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075731-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075731-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075731-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075731-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075731-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075731-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075731-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075731-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075731-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075731-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075731-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075731-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075731-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075731-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075731-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075731-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075731-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075731-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075731-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075731-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075731-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075731-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075731-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075731-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075731-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075731-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075731-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075731-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075731-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Clorazepate Dipotassium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLORAZEPATE DIPOTASSIUM | 3.75 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 63FN7G03XY | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| fb5c9e98-02b2-4c36-b436-25b58fe3c7d5 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72603-112-01 | Clorazepate Dipotassium | 100 in 1 BOTTLE | TABLET | 100 | 4 | |
| 72603-112-02 | Clorazepate Dipotassium | 500 in 1 BOTTLE | TABLET | 500 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72603-112-01 | EA - Each | 72603-112 | baf69e1d-d038-46a7-9c9f-5925b27cd91a | 1 | 2022-12-07 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Clorazepate Dipotassium | CLORAZEPATE DIPOTASSIUM | Clinical Solutions Wholesale, LLC | 11b72861-64c9-4cdc-9289-c7fa9ea23bf6 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 075731 ANDA075731 |
| Clorazepate Dipotassium | CLORAZEPATE DIPOTASSIUM | Sun Pharmaceutical Industries, Inc. | 499a6989-8912-44b7-b1eb-ee8f85ae378f | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | 075731 ANDA075731 |
| Clorazepate Dipotassium | CLORAZEPATE DIPOTASSIUM | Coupler LLC | 40074ed8-0799-e3e0-e063-6394a90ad200 | 2025-09-30 | Boxed warning, Warnings, Adverse reactions | 075731 ANDA075731 |
| Clorazepate Dipotassium | CLORAZEPATE DIPOTASSIUM | PD-Rx Pharmaceuticals, Inc. | 7b59a3ab-3dff-4458-a63a-ef0d9e0d996d | 2025-02-17 | Boxed warning, Warnings, Adverse reactions | 075731 ANDA075731 |
| Clorazepate Dipotassium | CLORAZEPATE DIPOTASSIUM | Coupler LLC | 2ccaf945-0369-3129-e063-6394a90a2740 | 2025-01-28 | Boxed warning, Warnings, Adverse reactions | 075731 ANDA075731 |
| Clorazepate Dipotassium | CLORAZEPATE DIPOTASSIUM | NORTHSTAR RX LLC | fb5c9e98-02b2-4c36-b436-25b58fe3c7d5 | 2024-10-28 | Boxed warning, Warnings, Adverse reactions | 075731 ANDA075731 72603-112 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 197464 | clorazepate dipotassium 15 MG Oral Tablet | PSN | fb5c9e98-02b2-4c36-b436-25b58fe3c7d5 | 4 |
| 197465 | clorazepate dipotassium 3.75 MG Oral Tablet | PSN | fb5c9e98-02b2-4c36-b436-25b58fe3c7d5 | 4 |
| 197466 | clorazepate dipotassium 7.5 MG Oral Tablet | PSN | fb5c9e98-02b2-4c36-b436-25b58fe3c7d5 | 4 |
| 197464 | clorazepate dipotassium 15 MG Oral Tablet | SCD | fb5c9e98-02b2-4c36-b436-25b58fe3c7d5 | 4 |
| 197465 | clorazepate dipotassium 3.75 MG Oral Tablet | SCD | fb5c9e98-02b2-4c36-b436-25b58fe3c7d5 | 4 |
| 197466 | clorazepate dipotassium 7.5 MG Oral Tablet | SCD | fb5c9e98-02b2-4c36-b436-25b58fe3c7d5 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 72603-112-01 | 72603011201 | 100 TABLET in 1 BOTTLE (72603-112-01) | 100 tablet | 2022-10-24 | 0000-00-00 | No | No | Current |
| 72603-112-02 | 72603011202 | 500 TABLET in 1 BOTTLE (72603-112-02) | 500 tablet | 2022-10-24 | 0000-00-00 | No | No | Current |