Prescription drug · ANDA
Doxepin Hydrochloride NDC 72205-091
Doxepin hydrochloride 75 mg/1 · Capsule · Oral · Novadoz Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72205-091-91 | 72205009191 | 100 CAPSULE in 1 BOTTLE, PLASTIC (72205-091-91)Marketed from Jun 27, 2022 | |
| 72205-091-99 | 72205009199 | 1000 CAPSULE in 1 BOTTLE, PLASTIC (72205-091-99)Marketed from Jun 27, 2022 |
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
- Novadoz Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215113
- Marketing start
- Listing expires
- Identifiers
- Product ID 72205-091_ba006e62-710f-4f97-ba98-506365d5cc44SPL ID ba006e62-710f-4f97-ba98-506365d5cc44SPL set ID 2b1f0144-65d8-451f-8054-6be1675f102cRxCUI 1000048, 1000058, 1000070, 1000076, 1000097UNII 3U9A0FE9N5UPC 0372205088917, 0372205091917, 0372205092990, 0372205092914, 0372205090910, 0372205089914, 0372205089990, 0372205091993, 0372205088993, 0372205090996
- 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
N472205009191followed by a unit qualifier and the quantityPackage 72205-0091-91. 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.
Other NDCs under ANDA 215113
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 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2804 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4179 |
| Doxepin HCL | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Direct_Rx | 72189-633 |
| Doxepin Hydrochloride | Doxepin hydrochloride 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4222 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4231 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4238 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4252 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2418 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-2452 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Proficient Rx LP | 82804-305 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-090 |
| Doxepin Hydrochloride | Doxepin hydrochloride 10 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-088 |
| Doxepin Hydrochloride | Doxepin hydrochloride 25 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-089 |
| Doxepin Hydrochloride | Doxepin hydrochloride 100 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-092 |
| Doxepin Hydrochloride | Doxepin hydrochloride 50 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-7819 |