Prescription drug · ANDA
Doxepin Hydrochloride NDC 81469-418
Doxepin hydrochloride 75 mg/1 · Capsule · Oral · First Nation Group, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81469-418-01 | 81469041801 | 100 CAPSULE in 1 BOTTLE (81469-418-01)Marketed from Jan 11, 2023 | |
| 81469-418-05 | 81469041805 | 500 CAPSULE in 1 BOTTLE (81469-418-05)Marketed from Jan 11, 2023 |
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 — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- First Nation Group, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215710
- Marketing start
- Listing expires
- Identifiers
- Product ID 81469-418_55da757c-42d2-4963-b06f-def9f18a423fSPL ID 55da757c-42d2-4963-b06f-def9f18a423fSPL set ID 3d4f84a4-07a1-4d0e-85f5-dcd43b236a42RxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 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
N481469041801followed by a unit qualifier and the quantityPackage 81469-0418-01. 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 are indicated for the treatment of major depressive disorder (MDD) in adults. Doxepin hydrochloride capsules are a tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215710
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 | First Nation Group, LLC | 81469-419 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | First Nation Group, LLC | 81469-417 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 83209-424 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | First Nation Group, LLC | 81469-416 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | First Nation Group, LLC | 81469-415 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-393 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-390 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-391 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-392 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | NorthStar RxLLC | 72603-394 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Lifestar Pharma LLC | 70756-426 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Lifestar Pharma LLC | 70756-424 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Lifestar Pharma LLC | 70756-425 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | Lifestar Pharma LLC | 70756-427 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Lifestar Pharma LLC | 70756-428 |
| Doxepin HCL | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Direct_rx | 72189-590 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2817 |