TEMAZEPAM
- Product NDC
- 0406-9962
- 11-digit product format
- 004069962
- Labeler code
- 0406
- Product ID
- 0406-9962_2794b069-e886-4191-9227-2b6c5e569b19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- NDA018163
- Marketing category
- NDA
- Marketing start
- 2010-02-23
- Substance
- TEMAZEPAM
- Active strength
- 30 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 | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CHB1QD2QSS |
| Rxcui | 198241, 198242, 198243, 485489 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0406-9962-01 | TEMAZEPAM | 100 in 1 BOTTLE | CAPSULE | 100 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TEMAZEPAM | ACTIVE INGREDIENT | CHB1QD2QSS | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| TEMAZEPAM | ACTIVE MOIETY | CHB1QD2QSS | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| ETHYL ACETATE | INACTIVE INGREDIENT | 76845O8NMZ | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TEMAZEPAM CAPSULE [MALLINCKRODT, INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-9962 | TEMAZEPAM CAPSULE [SPECGX LLC] | 15 | Current NDC, Legacy NDC, 1 package rows | 20240517_c9bc61b4-a579-4003-98da-b6f6e381c150.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 |
|---|
| 0406-9962-01 | 00406996201 | 100 CAPSULE in 1 BOTTLE (0406-9962-01) | 100 capsule | 2010-02-23 | 0000-00-00 | No | No | Current |