Prescription drug · ANDA
Doxepin hydrochloride NDC 72205-053
Doxepin hydrochloride 6 mg/1 · Tablet · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-053-05 | 7220500530572205005305 | 500 TABLET in 1 BOTTLE (72205-053-05)Marketed from Apr 5, 2023 | |
| 72205-053-30 | 7220500533072205005330 | 30 TABLET in 1 BOTTLE (72205-053-30)Marketed from Apr 5, 2023 | |
| 72205-053-91 | 7220500539172205005391 | 100 TABLET in 1 BOTTLE (72205-053-91)Marketed from Apr 5, 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 — 6 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Novadoz Pharmaceuticals LLCNDC labeler code 72205
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214823
- Marketing start
- Listing expires
- Identifiers
- Product ID 72205-053_da77c05e-0081-4f48-b3cf-2a378739a968SPL ID da77c05e-0081-4f48-b3cf-2a378739a968SPL set ID 96086fd8-8fa3-4a2b-ac12-fe1a3ad4f384RxCUI 966787, 966793UNII 3U9A0FE9N5UPC 0372205052918, 0372205053304, 0372205052307, 0372205052055, 0372205053052, 0372205053915
- 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
N472205005305followed by a unit qualifier and the quantityPackage 72205-0053-05. 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 .
Indications (excerpt from the label)
Doxepin tablets are indicated for the treatment of insomnia characterized by difficulty with sleep maintenance. The clinical trials performed in support of efficacy were up to 3 months in duration. Doxepin tablets are indicated for the treatment of insomnia characterized by difficulties with sleep maintenance. ( 1 , 14 )
Excerpt only. Read the full label for complete information.
About NDC 72205-053
- What is NDC 72205-053?
- 72205-053 is the product NDC for Doxepin hydrochloride, Doxepin hydrochloride 6 mg/1 tablet, listed with the FDA by Novadoz Pharmaceuticals LLC. It has 3 package NDCs, 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?
- Novadoz Pharmaceuticals LLC, NDC labeler code 72205. 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 214823
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 3 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-811 |
| Doxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-812 |
| Doxepin hydrochloride | Doxepin hydrochloride 6 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4297 |
| Doxepin hydrochloride | Doxepin hydrochloride 3 mg/1 | TabletOral | Novadoz Pharmaceuticals LLC | 72205-052 |