Prescription drug · ANDA
Temazepam NDC 68788-8493
Temazepam 15 mg/1 · Capsule · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8493-3 | 6878884930368788849303 | 30 CAPSULE in 1 BOTTLE (68788-8493-3)Marketed from Jul 24, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Temazepam
- Generic name (nonproprietary)
- temazepam
- Active ingredients
- Temazepam — 15 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211542
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 68788-8493_dfccb0bc-8e94-4d3a-b914-12bc110ffba4SPL ID dfccb0bc-8e94-4d3a-b914-12bc110ffba4SPL set ID cbe5bd6a-f36a-4557-82d8-ef4e49d310e9RxCUI 198241UNII CHB1QD2QSS
- Pharmacologic class
- Benzodiazepine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468788849303followed by a unit qualifier and the quantityPackage 68788-8493-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam capsules should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment.
Excerpt only. Read the full label for complete information.
About NDC 68788-8493
- What is NDC 68788-8493?
- 68788-8493 is the product NDC for Temazepam, Temazepam 15 mg/1 capsule, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Temazepam.
- What is the active ingredient?
- Temazepam.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Temazepam?
- 83 other product NDCs are listed under this name. See all Temazepam NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Temazepam products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-556 | 53746-0556-0153746-0556-05 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Amneal Pharmaceuticals of New York LLC | 53746-557 | 53746-0557-0153746-0557-05 |
| temazepam | Temazepam 15 mg/1 | CapsuleOral | AvPAK | 50268-779 | 50268-0779-15 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | AvPAK | 50268-780 | 50268-0780-13 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0295 | 80425-0295-0180425-0295-0280425-0295-03 |
| Temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Solco Healthcare U.S., LLC | 43547-611 | 43547-0611-10 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Solco Healthcare U.S., LLC | 43547-612 | 43547-0612-1043547-0612-50 |
| Temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Solco Healthcare U.S., LLC | 43547-613 | 43547-0613-03 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Solco Healthcare U.S., LLC | 43547-614 | 43547-0614-1043547-0614-50 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0191 | 80425-0191-0180425-0191-02 |
Other NDCs under ANDA 211542
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-379 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-380 |
| Temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-381 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-382 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-507 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-508 |
| Temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-379 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-380 |
| Temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-381 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-382 |
| Temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2043 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9741 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-986 |