Prescription drug · ANDA
Doxepin NDC 10135-764
Doxepin hydrochloride 6 mg/1 · Tablet, Film coated · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-764-30 | 10135076430 | 30 TABLET, FILM COATED in 1 BOTTLE (10135-764-30)Marketed from Oct 1, 2023 |
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
- Generic name (nonproprietary)
- doxepin
- Active ingredients
- Doxepin hydrochloride — 6 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202337
- Marketing start
- Listing expires
- Identifiers
- Product ID 10135-764_43029ddd-8941-add8-e063-6394a90a1e4dSPL ID 43029ddd-8941-add8-e063-6394a90a1e4dSPL set ID 06e79a65-1455-804e-e063-6394a90a2f3dRxCUI 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
N410135076430followed by a unit qualifier and the quantityPackage 10135-0764-30. 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)
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.