Prescription drug · ANDA
Duloxetine NDC 72162-1058
Duloxetine hydrochloride 60 mg/1 · Capsule, Delayed release pellets · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1058-3 | 72162105803 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (72162-1058-3)Marketed from Aug 1, 2024 |
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)
- Duloxetine
- Generic name (nonproprietary)
- duloxetine
- Active ingredients
- Duloxetine hydrochloride — 60 mg/1
- Dosage form
- Capsule, Delayed release pellets
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090776
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 72162-1058_6a478b7d-f27e-4e8e-9afb-ff8c53e2f93aSPL ID 6a478b7d-f27e-4e8e-9afb-ff8c53e2f93aSPL set ID 4673ccdd-c86c-4ddc-b462-941897ecfd22RxCUI 596934UNII 9044SC542W
- Pharmacologic class
- Serotonin and Norepinephrine Reuptake Inhibitor
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
N472162105803followed by a unit qualifier and the quantityPackage 72162-1058-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 090776
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 |
|---|---|---|---|---|
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | HAWAII REPACK, INC | 85534-0050 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | HAWAII REPACK, INC | 85534-0051 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 63629-8748 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 71335-1445 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Actavis Pharma, Inc. | 0228-2890 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Actavis Pharma, Inc. | 0228-2891 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Actavis Pharma, Inc. | 0228-2892 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Preferred Phamaceuticals Inc. | 68788-4025 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Preferred Phamaceuticals Inc. | 68788-4026 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Asclemed USA, Inc. | 76420-236 |
| Duloxetine HCL DRduloxetine hcl | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Advanced Rx of Tennessee, LLC | 80425-0086 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | HAWAII REPACK, INC | 85534-0017 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | NuCare Pharmaceuticals,Inc. | 68071-3779 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Proficient Rx LP | 71205-525 |