Prescription drug · ANDA
Temazepam NDC 46708-380
Temazepam 15 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-380-30 | 46708038030 | 30 CAPSULE in 1 BOTTLE (46708-380-30)Marketed from Nov 27, 2018 | |
| 46708-380-31 | 46708038031 | 100 CAPSULE in 1 BOTTLE (46708-380-31)Marketed from Nov 27, 2018 | |
| 46708-380-71 | 46708038071 | 500 CAPSULE in 1 BOTTLE (46708-380-71)Marketed from Nov 27, 2018 | |
| 46708-380-90 | 46708038090 | 90 CAPSULE in 1 BOTTLE (46708-380-90)Marketed from Nov 27, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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
- 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 46708-380_387adad5-eb5e-429f-bc8a-b9ace387bc3fSPL ID 387adad5-eb5e-429f-bc8a-b9ace387bc3fSPL set ID db839409-8e95-41d3-804e-dcd5d11f4934RxCUI 198241, 198242, 198243, 485489UNII CHB1QD2QSSUPC 0346708379308, 0346708382308, 0346708380304, 0346708381301
- 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
N446708038030followed by a unit qualifier and the quantityPackage 46708-0380-30. 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.
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 15 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8493 |
| Temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-379 |
| 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 | Alembic Pharmaceuticals Inc. | 62332-380 |
| Temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-379 |
| 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 30 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-508 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-507 |
| Temazepam | Temazepam 15 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9741 |
| Temazepam | Temazepam 30 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-986 |
| Temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2043 |