Prescription drug · ANDA
Doxepin Hydrochloride NDC 62332-640
Doxepin hydrochloride 100 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-640-31 | 62332064031 | 100 CAPSULE in 1 BOTTLE (62332-640-31)Marketed from Apr 23, 2021 | |
| 62332-640-91 | 62332064091 | 1000 CAPSULE in 1 BOTTLE (62332-640-91)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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215076
- Marketing start
- Listing expires
- Identifiers
- Product ID 62332-640_c3977b05-a9fc-4cc4-adfc-731abe6613ddSPL ID c3977b05-a9fc-4cc4-adfc-731abe6613ddSPL set ID 4920401a-cde5-404b-82aa-c3c0e8911065RxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 3U9A0FE9N5UPC 0362332645312
- 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
N462332064031followed by a unit qualifier and the quantityPackage 62332-0640-31. 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)
Doxepin hydrochloride capsule is indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride capsule is a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
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 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 10 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-637 |
| 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 |