Temazepam
- Product NDC
- 40032-121
- 11-digit product format
- 400320121
- Labeler code
- 40032
- Product ID
- 40032-121_8bfc2252-e630-499c-9a04-d408bf9f9b7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Novel Laboratories, Inc.
- Application
- ANDA071456
- Marketing category
- ANDA
- Marketing start
- 2009-10-01
- Marketing end
- 0000-00-00
- Substance
- TEMAZEPAM
- Active strength
- 15 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 40032-121-24 | Temazepam | 100 in 1 BOTTLE | CAPSULE | 100 | | 4 |
| 40032-121-26 | Temazepam | 500 in 1 BOTTLE | CAPSULE | 500 | | 4 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TEMAZEPAM | ACTIVE INGREDIENT | CHB1QD2QSS | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| TEMAZEPAM | ACTIVE MOIETY | CHB1QD2QSS | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 40032-121 | TEMAZEPAM CAPSULE [NOVEL LABORATORIES, INC.] | 4 | Legacy NDC, 2 package rows | 20120812_85327378-86a3-4448-9185-e20bb20ebf45.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 40032-121-24 | 40032012124 | 100 in 1 BOTTLE | Historical |
| 40032-121-26 | 40032012126 | 500 in 1 BOTTLE | Historical |