Prescription drug · ANDA
doxepin NDC 72578-182
Doxepin hydrochloride 6 mg/1 · Tablet · Oral · Viona Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-182-01 | 72578018201 | 100 TABLET in 1 BOTTLE (72578-182-01)Marketed from Jun 30, 2024 | |
| 72578-182-05 | 72578018205 | 500 TABLET in 1 BOTTLE (72578-182-05)Marketed from Jun 30, 2024 | |
| 72578-182-06 | 72578018206 | 30 TABLET in 1 BOTTLE (72578-182-06)Marketed from Jun 30, 2024 | |
| 72578-182-10 | 72578018210 | 1000 TABLET in 1 BOTTLE (72578-182-10)Marketed from Jun 30, 2024 | |
| 72578-182-16 | 72578018216 | 90 TABLET in 1 BOTTLE (72578-182-16)Marketed from Jun 30, 2024 | |
| 72578-182-77 | 72578018277 | 10 BLISTER PACK in 1 CARTON (72578-182-77) / 10 TABLET in 1 BLISTER PACKMarketed from Jun 30, 2024 |
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
- Route
- Oral
- Labeler
- Viona Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202761
- Marketing start
- Listing expires
- Identifiers
- Product ID 72578-182_d569143c-aee2-4e03-988d-1ef10950e7ceSPL ID d569143c-aee2-4e03-988d-1ef10950e7ceSPL set ID 3377541d-db46-4fd9-9a4b-faa5f6108e67RxCUI 966787, 966793UNII 3U9A0FE9N5UPC 0372578181062, 0372578182069
- 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
N472578018201followed by a unit qualifier and the quantityPackage 72578-0182-01. 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 difficulties with sleep maintenance. ( 1 , 14 ) 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.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202761
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 | TabletOral | Zydus Lifesciences Limited | 70771-1528 |
| doxepin | Doxepin hydrochloride 6 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1529 |
| doxepin | Doxepin hydrochloride 3 mg/1 | TabletOral | Viona Pharmaceuticals Inc | 72578-181 |