Prescription drug · NDA AUTHORIZED GENERIC
doxepin hydrochloride NDC 44183-103
Doxepin hydrochloride 3 mg/1 · Tablet · Oral · Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 44183-103-30 | 44183010330 | 30 TABLET in 1 BOTTLE (44183-103-30)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)
- doxepin hydrochloride
- Generic name (nonproprietary)
- doxepin hydrochloride
- Active ingredients
- Doxepin hydrochloride — 3 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022036
- Marketing start
- Listing expires
- Identifiers
- Product ID 44183-103_db184464-82a3-4710-a6aa-6a1c437a7bfcSPL ID db184464-82a3-4710-a6aa-6a1c437a7bfcSPL set ID 5b4dba99-6b66-4091-94f1-bf5f021c688aRxCUI 966787, 966793UNII 3U9A0FE9N5
- 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
N444183010330followed by a unit qualifier and the quantityPackage 44183-0103-30. 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 .
Indications (excerpt from the label)
1. INDICATIONS AND USAGE Doxepin HCl Tablets 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. Doxepin HCl 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 |
| Silenordoxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Currax Pharmaceuticals LLC | 42847-106 |
| Silenordoxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Currax Pharmaceuticals LLC | 42847-103 |