Temazepam
- Product NDC
- 68084-549
- 11-digit product format
- 680840549
- Labeler code
- 68084
- Product ID
- 68084-549_437ec164-740f-2419-e063-6294a90a17e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- NDA018163
- Marketing category
- NDA
- Marketing start
- 2012-08-01
- Substance
- TEMAZEPAM
- 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
- Temazepam
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TEMAZEPAM | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CHB1QD2QSS |
| Rxcui | 198243 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-549-11 | Temazepam | 1 in 1 BLISTER PACK | CAPSULE | 1 | | 10 |
| 68084-549-21 | Temazepam | 30 in 1 BOX, UNIT-DOSE | CAPSULE | 30 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-549 | TEMAZEPAM CAPSULE [AMERICAN HEALTH PACKAGING] | 9 | Current NDC, Legacy NDC, 2 package rows | 20240131_a3f06243-fa03-4cbd-951a-144ec43dcdfd.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 |
|---|
| 68084-549-11 | 68084054911 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 68084-549-21 | 68084054921 | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-549-21) / 1 CAPSULE in 1 BLISTER PACK (68084-549-11) | 30 blister pack | 2012-08-01 | 0000-00-00 | No | No | Current |