Prescription drug · ANDA
Doxepin NDC 0228-3316
Doxepin hydrochloride 6 mg/1 · Tablet, Film coated · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0228-3316-03 | 00228331603 | 30 TABLET, FILM COATED in 1 BOTTLE (0228-3316-03)Marketed from Jan 2, 2020 |
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)
- Doxepin
- Generic name (nonproprietary)
- doxepin
- Active ingredients
- Doxepin hydrochloride — 6 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201951
- Marketing start
- Listing expires
- Identifiers
- Product ID 0228-3316_7f10f9b0-b39a-49a0-a3ea-01ae9ac49f33SPL ID 7f10f9b0-b39a-49a0-a3ea-01ae9ac49f33SPL set ID c42333f8-1add-4f33-9458-6fe4436874a1RxCUI 966787, 966793UNII 3U9A0FE9N5UPC 0302283316039
- 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
N400228331603followed by a unit qualifier and the quantityPackage 00228-3316-03. 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)
Doxepin tablets are 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 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 ANDA 201951
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 | Doxepin hydrochloride 3 mg/1 | Tablet, Film coatedOral | Actavis Pharma, Inc. | 0228-3315 |