Prescription drug · ANDA
Temazepam NDC 0904-6436
Temazepam 7.5 mg/1 · Capsule · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6436-04 | 00904643604 | 30 BLISTER PACK in 1 CARTON (0904-6436-04) / 1 CAPSULE in 1 BLISTER PACKMarketed from Mar 25, 2015 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 7.5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071457
- Marketing start
- Listing expires
- DEA schedule
- CIV
- Other FDA classes
- Benzodiazepines (Chemical structure)
- Identifiers
- Product ID 0904-6436_b8a4c104-146e-411e-aeab-21cf875a2d0cSPL ID b8a4c104-146e-411e-aeab-21cf875a2d0cSPL set ID 2c4f564d-d349-4f9b-b3f4-f3f0d9706a4dRxCUI 198243UNII CHB1QD2QSSUPC 0309046436607
- 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
N400904643604followed by a unit qualifier and the quantityPackage 00904-6436-04. 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 & USAGE Temazepam Capsules, USP 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 071457
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 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1057 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Preferred Pharmaceuticals Inc. | 68788-8081 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1825 |
| temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1826 |
| temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-1827 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Proficient Rx LP | 71205-915 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2910 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-260 |
| temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8601 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8605 |
| temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8604 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8606 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2965 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-1621 |
| temazepam | Temazepam 22.5 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-474 |
| temazepam | Temazepam 7.5 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-472 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Asclemed USA, Inc. | 76420-475 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 55289-660 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | Proficient Rx LP | 63187-497 |
| temazepam | Temazepam 30 mg/1 | CapsuleOral | AvPAK | 50268-780 |
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