Prescription drug · ANDA
Doxepin Hydrochloride NDC 63629-5033
Doxepin hydrochloride 25 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-5033-1 | 63629503301 | 30 CAPSULE in 1 BOTTLE (63629-5033-1)Marketed from Jun 12, 2013 | |
| 63629-5033-2 | 63629503302 | 60 CAPSULE in 1 BOTTLE (63629-5033-2)Marketed from Jun 2, 2016 | |
| 63629-5033-3 | 63629503303 | 28 CAPSULE in 1 BOTTLE (63629-5033-3)Marketed from Oct 8, 2024 | |
| 63629-5033-4 | 63629503304 | 18 CAPSULE in 1 BOTTLE (63629-5033-4)Marketed from Oct 8, 2024 | |
| 63629-5033-5 | 63629503305 | 90 CAPSULE in 1 BOTTLE (63629-5033-5)Marketed from Oct 8, 2024 |
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
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070791
- Marketing start
- Listing expires
- Identifiers
- Product ID 63629-5033_c7bcdac5-b245-4e00-b92d-5134fc2f5e03SPL ID c7bcdac5-b245-4e00-b92d-5134fc2f5e03SPL set ID c577af7c-2405-4454-a169-5b6a4fa0c7bfRxCUI 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
N463629503301followed by a unit qualifier and the quantityPackage 63629-5033-01. 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)
INDICATIONS AND USAGE Doxepin Hydrochloride Capsules, USP are recommended for the treatment of: 1. Psychoneurotic patients with depression and/or anxiety. 2. Depression and/or anxiety associated with alcoholism (not to be taken concomitantly with alcohol). 3. Depression and/or anxiety associated with organic disease (the possibility of drug interaction should be considered if the patient is receiving other drugs concomitantly). 4. 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, som…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070791
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 100 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-651 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-4250 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-5375 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-329 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 43353-331 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-072 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 55289-370 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-1049 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-6410 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Mylan Pharmaceuticals Inc. | 0378-3125 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-035 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-036 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-037 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-038 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-437 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-436 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Mylan Institutional Inc. | 51079-438 |