Estazolam
- Product NDC
- 0591-0744
- 11-digit product format
- 005910744
- Labeler code
- 0591
- Product ID
- 0591-0744_5189e5a6-f58a-4eab-ac95-9d8011d6f3db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estazolam
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA074818
- Marketing category
- ANDA
- Marketing start
- 1997-10-01
- Substance
- ESTAZOLAM
- Active strength
- 1 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 | 1 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 |
|---|
| 0591-0744-01 | Estazolam | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 23 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ESTAZOLAM | ACTIVE INGREDIENT | 36S3EQV54C | ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] | 6 | |
| ESTAZOLAM | ACTIVE MOIETY | 36S3EQV54C | ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] | 6 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] | 6 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] | 6 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] | 6 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] | 6 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | ESTAZOLAM TABLET [WATSON LABORATORIES, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0591-0744 | ESTAZOLAM TABLET [ACTAVIS PHARMA, INC.] | 22 | Current NDC, Legacy NDC, 1 package rows | 20230125_a1e3b4bf-22e9-430a-a768-4d86ae886c9e.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 |
|---|
| 0591-0744-01 | 00591074401 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-0744-01) | 100 tablet | 1997-10-01 | 0000-00-00 | No | No | Current |