RESTORIL
- Product NDC
- 0406-9914
- 11-digit product format
- 004069914
- Labeler code
- 0406
- Product ID
- 0406-9914_300ed63a-6bbc-4dbd-ba1d-e4eda4737e09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- SpecGx LLC
- Application
- NDA018163
- Marketing category
- NDA
- Marketing start
- 1981-02-27
- Substance
- TEMAZEPAM
- Active strength
- 22.5 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
- RESTORIL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TEMAZEPAM | 22.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | CHB1QD2QSS |
| Rxcui | 198241, 198242, 198243, 208463, 208464, 208465, 485489, 539384 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0406-9914-03 | RESTORIL | 30 in 1 BOTTLE | CAPSULE | 30 | | 24 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| TEMAZEPAM | ACTIVE INGREDIENT | CHB1QD2QSS | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| TEMAZEPAM | ACTIVE MOIETY | CHB1QD2QSS | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| BUTYL ALCOHOL | INACTIVE INGREDIENT | 8PJ61P6TS3 | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| ETHYL ACETATE | INACTIVE INGREDIENT | 76845O8NMZ | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| FD&C RED NO. 3 | INACTIVE INGREDIENT | PN2ZH5LOQY | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| ISOPROPYL ALCOHOL | INACTIVE INGREDIENT | ND2M416302 | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | RESTORIL (TEMAZEPAM) CAPSULE [MALLINCKRODT, INC.] | 8 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0406-9914 | RESTORIL (TEMAZEPAM) CAPSULE [SPECGX LLC] | 24 | Current NDC, Legacy NDC, 1 package rows | 20240517_bc56f7fd-1aaf-48ff-8aa7-d467e59e1015.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 |
|---|
| 0406-9914-03 | 00406991403 | 30 CAPSULE in 1 BOTTLE (0406-9914-03) | 30 capsule | 1981-02-27 | 0000-00-00 | No | No | Current |