CLORAZEPATE DIPOTASSIUM
- Product NDC
- 13107-283
- 11-digit product format
- 131070283
- Labeler code
- 13107
- Product ID
- 13107-283_69451c35-dd9a-4690-8d5e-4dcfa8837620
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- CLORAZEPATE DIPOTASSIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aurolife Pharma LLC
- Application
- ANDA071858
- Marketing category
- ANDA
- Marketing start
- 2023-09-23
- Substance
- CLORAZEPATE DIPOTASSIUM
- Active strength
- 7.5 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
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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 63FN7G03XY |
| Rxcui | 197464, 197465, 197466 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13107-283-01 | CLORAZEPATE DIPOTASSIUM | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 1 |
| 13107-283-05 | CLORAZEPATE DIPOTASSIUM | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13107-283 | CLORAZEPATE DIPOTASSIUM TABLET [AUROLIFE PHARMA LLC] | 1 | Current NDC, 2 package rows | 20240123_69451c35-dd9a-4690-8d5e-4dcfa8837620.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 13107-283-01 | 13107028301 | 100 TABLET in 1 BOTTLE, PLASTIC (13107-283-01) | 100 tablet | 2023-09-23 | No | No | Current |
| 13107-283-05 | 13107028305 | 500 TABLET in 1 BOTTLE, PLASTIC (13107-283-05) | 500 tablet | 2023-09-23 | No | No | Current |