Prescription drug · ANDA
Doxepin Hydrochloride NDC 23155-797
Doxepin hydrochloride 75 mg/1 · Capsule · Oral · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23155-797-01 | 2315507970123155079701 | 100 CAPSULE in 1 BOTTLE (23155-797-01)Marketed from Dec 30, 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 — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.NDC labeler code 23155
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214908
- Marketing start
- Listing expires
- Identifiers
- Product ID 23155-797_b170c5a1-48e2-4532-8324-cce5229fe09bSPL ID b170c5a1-48e2-4532-8324-cce5229fe09bSPL set ID 89ed6385-cf6a-458e-81ea-c7f3fead41c5RxCUI 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
N423155079701followed by a unit qualifier and the quantityPackage 23155-0797-01. 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 is indicated for the treatment of major depressive disorder (MDD) in adults. • Doxepin hydrochloride capsules are tricyclic antidepressant (TCA) indicated for the treatment of major depressive disorder (MDD) in adults.
Excerpt only. Read the full label for complete information.
About NDC 23155-797
- What is NDC 23155-797?
- 23155-797 is the product NDC for Doxepin Hydrochloride, Doxepin hydrochloride 75 mg/1 capsule, listed with the FDA by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.. 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?
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc., NDC labeler code 23155. 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 214908
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 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-794 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-795 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-796 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-798 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Appco Pharma LLC | 55801-527 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Appco Pharma LLC | 55801-528 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Appco Pharma LLC | 55801-529 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | Appco Pharma LLC | 55801-530 |
| Doxepin Hydrochloridedoxepn hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Appco Pharma LLC | 55801-531 |