Temazepam
- Product NDC
- 33358-332
- 11-digit product format
- 333580332
- Labeler code
- 33358
- Product ID
- 33358-332_97e69e3c-7c76-459d-882f-327435be01c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- RxChange Co.
- Application
- ANDA071638
- Marketing category
- ANDA
- Marketing start
- 2014-11-15
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a3aa44f1-a660-94b4-7185-b48df8b066ff | Product name | 5 | 20250522 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33358-332-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-66c4-f424-e053-dadaa90a57ce | TEMAZEPAM CAPSULES, USP CIV 40-9177 Revised – June 2012 Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33358-332-30 | Temazepam | 30 in 1 BOTTLE | CAPSULE | 30 | 2 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 33358-332-30 | EA - Each | 33358-332 | 8d218a3a-f0d0-4518-89b6-6e32ea981a4b | 1 | 2015-01-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TEMAZEPAM | ACTIVE INGREDIENT | CHB1QD2QSS | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 | |
| TEMAZEPAM | ACTIVE MOIETY | CHB1QD2QSS | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TEMAZEPAM CAPSULE [RXCHANGE CO.] | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198241 | temazepam 15 MG Oral Capsule | PSN | c270129a-03e8-4c3d-a47e-0e533f05b2ad | 2 |
| 198241 | temazepam 15 MG Oral Capsule | SCD | c270129a-03e8-4c3d-a47e-0e533f05b2ad | 2 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33358-332-30 | 33358033230 | 30 in 1 BOTTLE | Historical |