Estazolam
- Product NDC
- 70954-481
- 11-digit product format
- 709540481
- Labeler code
- 70954
- Product ID
- 70954-481_2a612458-8b9a-4125-a783-44327a8166d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estazolam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Novitium Pharma LLC
- Application
- ANDA074826
- Marketing category
- ANDA
- Marketing start
- 2021-04-08
- Substance
- ESTAZOLAM
- Active strength
- 2 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
- Estazolam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ESTAZOLAM | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 36S3EQV54C |
| Rxcui | 197653, 197654 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70954-481-10 | Estazolam | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70954-481 | ESTAZOLAM TABLET [NOVITIUM PHARMA LLC] | 3 | Current NDC, Legacy NDC, 1 package rows | 20221124_e1c77eb1-9cba-4e89-a03f-9fb797add4f0.zip |
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 |
|---|
| 70954-481-10 | 70954048110 | 100 TABLET in 1 BOTTLE (70954-481-10) | 100 tablet | 2021-04-08 | 0000-00-00 | No | No | Current |