Prescription drug · ANDA
Doxepin Hydrochloride NDC 59651-174
Doxepin hydrochloride 25 mg/1 · Capsule · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-174-01 | 5965101740159651017401 | 100 CAPSULE in 1 BOTTLE (59651-174-01)Marketed from Mar 27, 2019 |
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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211603
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-174_5b5efe70-cce2-4950-94f0-d3aa869e442eSPL ID 5b5efe70-cce2-4950-94f0-d3aa869e442eSPL set ID f3c242dd-426e-4c69-8f21-2645361d5f27RxCUI 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
N459651017401followed by a unit qualifier and the quantityPackage 59651-0174-01. 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 ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 59651-174
- What is NDC 59651-174?
- 59651-174 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 25 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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 50 mg/1 | CapsuleOral | Coupler LLC | 67046-0394 | 67046-0394-03 |
| 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 |
Other NDCs under ANDA 211603
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 | Aurobindo Pharma Limited | 59651-173 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-175 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-176 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 59651-177 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | NuCare Pharmaceuticals,Inc. | 68071-5179 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Proficient Rx LP | 71205-534 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Proficient Rx LP | 71205-610 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-220 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | PD-Rx Pharmaceuticals, Inc. | 72789-542 |