Temazepam
- Product NDC
- 0378-4010
- 11-digit product format
- 003784010
- Labeler code
- 0378
- Product ID
- 0378-4010_57e251a0-cc54-4ae9-818d-a2f168e3fb13
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA070920
- Marketing category
- ANDA
- Marketing start
- 1986-07-10
- Marketing end
- 0000-00-00
- Substance
- TEMAZEPAM
- Active strength
- 15 mg/1
- Pharmacologic classes
- Benzodiazepine [EPC],Benzodiazepines [CS]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TEMAZEPAM | ACTIVE INGREDIENT | CHB1QD2QSS | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| TEMAZEPAM | ACTIVE MOIETY | CHB1QD2QSS | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TEMAZEPAM CAPSULE [PHYSICIANS TOTAL CARE, INC.] | 4 | |
| TEMAZEPAM | ACTIVE INGREDIENT | CHB1QD2QSS | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| TEMAZEPAM | ACTIVE MOIETY | CHB1QD2QSS | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| POWDERED CELLULOSE | INACTIVE INGREDIENT | SMD1X3XO9M | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TEMAZEPAM CAPSULE [STAT RX USA LLC] | 3 | |
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 |
|---|
| 0378-4010-01 | 00378401001 | 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4010-01) | 100 capsule | 1986-07-10 | 0000-00-00 | No | No | Current |
| 0378-4010-05 | 00378401005 | 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-4010-05) | 500 capsule | 1986-07-10 | 0000-00-00 | No | No | Current |
| 0378-4010-77 | 00378401077 | 90 CAPSULE in 1 BOTTLE, PLASTIC (0378-4010-77) | 90 capsule | 1986-07-10 | 0000-00-00 | No | No | Current |