Prescription drug · ANDA
Doxepin hydrochloride NDC 51407-811
Doxepin hydrochloride 3 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-811-30 | 51407081130 | 30 TABLET in 1 BOTTLE (51407-811-30)Marketed from May 31, 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 hydrochloride
- Generic name (nonproprietary)
- doxepin hydrochloride
- Active ingredients
- Doxepin hydrochloride — 3 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214823
- Marketing start
- Listing expires
- Identifiers
- Product ID 51407-811_2a07fb40-8690-5729-e063-6294a90a4078SPL ID 2a07fb40-8690-5729-e063-6294a90a4078SPL set ID 00ef7d0b-4bb9-cd5b-e063-6294a90abc35RxCUI 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
N451407081130followed by a unit qualifier and the quantityPackage 51407-0811-30. 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.
Other NDCs under ANDA 214823
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 | REMEDYREPACK INC. | 70518-4297 |
| Doxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-812 |
| Doxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-052 |
| Doxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-053 |