Prescription drug · ANDA
Doxepin hydrochloride NDC 67046-0394
Doxepin hydrochloride 50 mg/1 · Capsule · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-0394-3 | 6704603940367046039403 | 30 CAPSULE in 1 BLISTER PACK (67046-0394-3)Marketed from Jun 16, 2026 |
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
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212624
- Marketing start
- Listing expires
- Identifiers
- Product ID 67046-0394_54616461-9652-4a24-e063-6394a90a5d02SPL ID 54616461-9652-4a24-e063-6394a90a5d02SPL set ID 54616c93-2325-4719-e063-6394a90a3910RxCUI 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
N467046039403followed by a unit qualifier and the quantityPackage 67046-0394-03. 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.
About NDC 67046-0394
- What is NDC 67046-0394?
- 67046-0394 is the product NDC for Doxepin hydrochloride, Doxepin hydrochloride 50 mg/1 capsule, listed with the FDA by Coupler LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Doxepin hydrochloride.
- What is the active ingredient?
- Doxepin hydrochloride.
- Who is the labeler?
- Coupler LLC, NDC labeler code 67046. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Doxepin hydrochloride?
- 173 other product NDCs are listed under this name. See all Doxepin hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Doxepin hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/g | CreamTopical | Sun Pharmaceutical Industries, Inc. | 51672-1404 | 51672-1404-0251672-1404-09 |
| Doxepin Hydrochloride | Doxepin hydrochloride 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4733 | 70518-4733-00 |
| Doxepin hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Coupler LLC | 67046-0393 | 67046-0393-03 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-035 | 48433-0035-20 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-036 | 48433-0036-20 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-037 | 48433-0037-20 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Safecor Health, LLC | 48433-038 | 48433-0038-20 |
| doxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4246 | 51672-4246-02 |
| doxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 51672-4247 | 51672-4247-02 |
| doxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-727 | 51407-0727-30 |
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 | Proficient Rx LP | 71205-695 |
| 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 75 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-170 |
| Doxepin hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Ajanta Pharma USA Inc. | 27241-171 |
| Doxepin hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2188 |
| Doxepin hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3594 |
| 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 |
| Doxepin hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3767 |
| Doxepin hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-9732 |
| Doxepin hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Coupler LLC | 67046-0393 |
| Doxepin hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2092 |