Prescription drug · ANDA
doxepin hydrochloride NDC 51672-4246
Doxepin hydrochloride 3 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51672-4246-2 | 51672424602 | 30 TABLET in 1 BOTTLE (51672-4246-2)Marketed from Aug 7, 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 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 219058
- Marketing start
- Listing expires
- Identifiers
- Product ID 51672-4246_36adb81c-3442-17dc-e063-6394a90aaafaSPL ID 36adb81c-3442-17dc-e063-6394a90aaafaSPL set ID 554ab06f-6420-42b3-89d1-d97554c237d8RxCUI 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
N451672424602followed by a unit qualifier and the quantityPackage 51672-4246-02. 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 is 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 219058
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 | Sun Pharmaceutical Industries, Inc. | 51672-4247 |
| doxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-727 |
| doxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-728 |