Prescription drug · ANDA
Doxepin Hydrochloride NDC 62135-562
Doxepin hydrochloride 50 mg/1 · Capsule · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-562-90 | 62135056290 | 90 CAPSULE in 1 BOTTLE (62135-562-90)Marketed from Nov 22, 2022 · Sample package |
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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210268
- Marketing start
- Listing expires
- Identifiers
- Product ID 62135-562_459bacaf-9b0a-6657-e063-6394a90a66cfSPL ID 459bacaf-9b0a-6657-e063-6394a90a66cfSPL set ID 33a15c3f-bec0-4703-a4e9-f8f78f8b5fd3RxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 3U9A0FE9N5UPC 0362135561901, 0362135562908, 0362135564902, 0362135560904, 0362135563905
- 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
N462135056290followed by a unit qualifier and the quantityPackage 62135-0562-90. 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)
INDICATIONS AND USAGE Doxepin hydrochloride capsules 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 include anxiety, tension, depression, somatic symptoms and concerns, sleep distur…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210268
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 10 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-560 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-561 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-563 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-564 |