Prescription drug · NDA
Silenor (doxepin hydrochloride) NDC 42847-106
Doxepin hydrochloride 6 mg/1 · Tablet · Oral · Currax Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42847-106-03 | 42847010603 | 30 TABLET in 1 BLISTER PACK (42847-106-03)Marketed from Aug 1, 2010 | |
| 42847-106-10 | 42847010610 | 100 TABLET in 1 BOTTLE (42847-106-10)Marketed from Aug 1, 2010 | |
| 42847-106-30 | 42847010630 | 30 TABLET in 1 BOTTLE (42847-106-30)Marketed from Aug 1, 2010 | |
| 42847-106-50 | 42847010650 | 500 TABLET in 1 BOTTLE (42847-106-50)Marketed from Aug 1, 2010 |
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)
- Silenor
- Generic name (nonproprietary)
- doxepin hydrochloride
- Active ingredients
- Doxepin hydrochloride — 6 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Currax Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022036
- Marketing start
- Listing expires
- Identifiers
- Product ID 42847-106_cd7bcf13-11a5-4866-9fd0-da073bb3a9a1SPL ID cd7bcf13-11a5-4866-9fd0-da073bb3a9a1SPL set ID 1bec1223-5239-4eb6-a9e8-62444106d2c0RxCUI 966787, 966791, 966793, 966795UNII 3U9A0FE9N5UPC 0342847103309, 0342847106300
- Pharmacologic class
- Tricyclic Antidepressant
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
N442847010603followed by a unit qualifier and the quantityPackage 42847-0106-03. 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 .
Indications (excerpt from the label)
1. INDICATIONS AND USAGE SILENOR is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration . SILENOR (doxepin) tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. ( 1 , 14 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022036
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 |
|---|---|---|---|---|
| doxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven | 44183-106 |
| doxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven | 44183-103 |
| Silenordoxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Currax Pharmaceuticals LLC | 42847-103 |