Prescription drug · ANDA
Doxepin (doxepin hydrochloride) NDC 70518-4327
Doxepin hydrochloride 6 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4327-0 | 70518432700 | 30 POUCH in 1 BOX (70518-4327-0) / 1 TABLET in 1 POUCH (70518-4327-1)Marketed from Apr 13, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 hydrochloride
- Active ingredients
- Doxepin hydrochloride — 6 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202510
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-4327_5aac15e9-41c2-f6f1-e063-6394a90a47dfSPL ID 5aac15e9-41c2-f6f1-e063-6394a90a47dfSPL set ID 2a9c2159-e89e-47e4-b91c-ac5560607a2dRxCUI 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
N470518432700followed by a unit qualifier and the quantityPackage 70518-4327-00. 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 202510
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 |
|---|---|---|---|---|
| Doxepindoxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-203 |
| Doxepindoxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-204 |
| Doxepindoxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2475 |
| Doxepindoxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2474 |