Prescription drug · ANDA
Doxepin hydrochloride NDC 70518-3767
Doxepin hydrochloride 50 mg/1 · Capsule · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3767-0 | 70518376700 | 30 CAPSULE in 1 BLISTER PACK (70518-3767-0)Marketed from Jun 16, 2023 |
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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212624
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-3767_54d6fad2-18cc-aabb-e063-6394a90aaa8eSPL ID 54d6fad2-18cc-aabb-e063-6394a90aaa8eSPL set ID 46be666a-fb9f-42a5-a55c-ea15fd5538c9RxCUI 1000076UNII 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
N470518376700followed by a unit qualifier and the quantityPackage 70518-3767-00. 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 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 212624
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 | REMEDYREPACK INC. | 70518-3594 |
| Doxepin hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9732 |
| Doxepin hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2092 |
| Doxepin hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-170 |
| Doxepin hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-167 |
| Doxepin hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-168 |
| Doxepin hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-169 |
| Doxepin hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-171 |
| Doxepin hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Coupler LLC | 67046-0393 |
| Doxepin hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Coupler LLC | 67046-0394 |
| Doxepin hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Proficient Rx LP | 71205-695 |
| Doxepin hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2188 |
| Doxepin hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Proficient Rx LP | 82804-011 |
| Doxepin HCL | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Direct_Rx | 72189-533 |