Prescription drug · ANDA
Doxepin Hydrochloride NDC 46708-637
Doxepin hydrochloride 10 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-637-31 | 46708063731 | 100 CAPSULE in 1 BOTTLE (46708-637-31)Marketed from Apr 23, 2021 | |
| 46708-637-91 | 46708063791 | 1000 CAPSULE in 1 BOTTLE (46708-637-91)Marketed from Apr 23, 2021 |
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 — 10 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215076
- Marketing start
- Listing expires
- Identifiers
- Product ID 46708-637_5c5c56f2-76f7-41b1-8eb5-40dc4cd4ac6aSPL ID 5c5c56f2-76f7-41b1-8eb5-40dc4cd4ac6aSPL set ID 842b595b-dc54-4898-a178-1d2241cc065fRxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 3U9A0FE9N5UPC 0346708638313, 0346708639310
- 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
N446708063731followed by a unit qualifier and the quantityPackage 46708-0637-31. 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 hydrochloride capsules include anxiety, tension, depression, somatic symptoms and…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215076
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 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2557 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0411 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-638 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2647 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-638 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-637 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-639 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-640 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-645 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4282 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-639 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-638 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-640 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-645 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7184 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2472 |
| Doxepin HCL | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Direct_rx | 72189-574 |