Temazepam
- Product NDC
- 50436-4628
- 11-digit product format
- 504364628
- Labeler code
- 50436
- Product ID
- 50436-4628_42cb6326-8341-47a6-82cd-f66c44ab95ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Temazepam
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Unit Dose Services
- Application
- ANDA071620
- Marketing category
- ANDA
- Marketing start
- 1990-09-30
- 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#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a3aa44f1-a660-94b4-7185-b48df8b066ff | Product name | 5 | 20250522 |
| 351abe41-466c-4dd8-840a-0fdb68318bd5 | Product name | 1 | 20230316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50436-4628-1 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5976-a910-e053-dadaa90a0b85 | Temazepam Capsules, USP CIV Rx only |
| 50436-4628-2 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5976-a910-e053-dadaa90a0b85 | Temazepam Capsules, USP CIV Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50436-4628-1 | Temazepam | 60 in 1 BOTTLE | CAPSULE | 60 | 13 | |
| 50436-4628-2 | Temazepam | 30 in 1 BOTTLE | CAPSULE | 30 | 13 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50436-4628-1 | EA - Each | 50436-4628 | 244fc3cf-ed7f-4db7-a65d-b0b94a2c4385 | 1 | 2013-04-01 |
| 50436-4628-2 | EA - Each | 50436-4628 | f8555f72-2943-495b-bf4e-0110e063300f | 1 | 2013-04-01 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TEMAZEPAM | ACTIVE INGREDIENT | CHB1QD2QSS | TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] | 5 | |
| TEMAZEPAM | ACTIVE MOIETY | CHB1QD2QSS | TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] | 5 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] | 5 | |
| FD&C GREEN NO. 3 | INACTIVE INGREDIENT | 3P3ONR6O1S | TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] | 5 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TEMAZEPAM CAPSULE [UNIT DOSE SERVICES] | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50436-4628 | TEMAZEPAM (TEMAZEPAM) CAPSULE [UNIT DOSE SERVICES] | 13 | Legacy NDC, 2 package rows | 20190531_dbd39517-62f5-44b0-844f-e1cbf3c6ca2e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198241 | temazepam 15 MG Oral Capsule | PSN | dbd39517-62f5-44b0-844f-e1cbf3c6ca2e | 13 |
| 198241 | temazepam 15 MG Oral Capsule | SCD | dbd39517-62f5-44b0-844f-e1cbf3c6ca2e | 13 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 50436-4628-1 | 50436462801 | 60 in 1 BOTTLE | Historical |
| 50436-4628-2 | 50436462802 | 30 in 1 BOTTLE | Historical |