Prescription drug · ANDA
Doxepin Hydrochloride NDC 80425-0316
Doxepin hydrochloride 25 mg/1 · Capsule · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0316-1 | 8042503160180425031601 | 30 CAPSULE in 1 BOTTLE (80425-0316-1)Marketed from Apr 10, 2023 | |
| 80425-0316-2 | 8042503160280425031602 | 60 CAPSULE in 1 BOTTLE (80425-0316-2)Marketed from Apr 10, 2023 | |
| 80425-0316-3 | 8042503160380425031603 | 90 CAPSULE in 1 BOTTLE (80425-0316-3)Marketed from Apr 10, 2023 |
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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213063
- Marketing start
- Listing expires
- Identifiers
- Product ID 80425-0316_2a9bf621-afbf-7627-e063-6294a90a77a9SPL ID 2a9bf621-afbf-7627-e063-6294a90a77a9SPL set ID f900bac4-02f2-6bf3-e053-6394a90a2161RxCUI 1000070UNII 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
N480425031601followed by a unit qualifier and the quantityPackage 80425-0316-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: Psychoneurotic patients with depression and/or anxiety. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). Psychotic depressive disorders with associated anxiety including involutional depression and manic-depressive disorders. The target symptoms of psychoneurosis that respond particularly well to doxepin hydrochloride capsules include anxiety, tension, depression, somatic symptoms and concerns, sleep …
Excerpt only. Read the full label for complete information.
About NDC 80425-0316
- What is NDC 80425-0316?
- 80425-0316 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 25 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxepin Hydrochloride.
- What is the active ingredient?
- Doxepin hydrochloride.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Doxepin Hydrochloride?
- 173 other product NDCs are listed under this name. See all Doxepin Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Doxepin Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-1404 | 51672-1404-0251672-1404-09 |
| Doxepin Hydrochloride | Doxepin hydrochloride 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4733 | 70518-4733-00 |
| Doxepin hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Coupler LLC | 67046-0394 | 67046-0394-03 |
| Doxepin hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Coupler LLC | 67046-0393 | 67046-0393-03 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-035 | 48433-0035-20 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-036 | 48433-0036-20 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-037 | 48433-0037-20 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-038 | 48433-0038-20 |
| doxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4246 | 51672-4246-02 |
| doxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4247 | 51672-4247-02 |
Other NDCs under ANDA 213063
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 HCL | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Direct_Rx | 72189-355 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5286 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | direct rx | 72189-161 |