Prescription drug · ANDA
Duloxetine NDC 43547-379
Duloxetine hydrochloride 20 mg/1 · Capsule, Delayed release · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-379-03 | 43547037903 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-03)Marketed from Jan 20, 2016 | |
| 43547-379-06 | 43547037906 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-06)Marketed from Jan 20, 2016 | |
| 43547-379-09 | 43547037909 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-09)Marketed from Jan 20, 2016 | |
| 43547-379-11 | 43547037911 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (43547-379-11)Marketed from Jan 20, 2016 |
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)
- Duloxetine
- Generic name (nonproprietary)
- duloxetine
- Active ingredients
- Duloxetine hydrochloride — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Solco Healthcare US, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206653
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 43547-379_ca41e20e-60e1-4134-83b8-e3b5f8732f4fSPL ID ca41e20e-60e1-4134-83b8-e3b5f8732f4fSPL set ID a105a648-6a97-4151-b9de-d7eac90a8f79RxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0343547380038, 0343547381035, 0343547379032
- 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
N443547037903followed by a unit qualifier and the quantityPackage 43547-0379-03. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Duloxetine delayed-release capsules are indicated for the treatment of: • Major depressive disorder in adults • Generalized anxiety disorder in adults and pediatric patients 7 years of age and older • Diabetic peripheral neuropathic pain in adults • Fibromyalgia in adults and pediatric patients 13 years of age and older • Chronic musculoskeletal pain in adults Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: • Major depressive disorder (MDD) in adults ( 1 ) • Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 ) • Diabetic peripheral neuropathic pain (DPNP) in adults ( …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206653
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 30 mg/1 | Capsule, Delayed releaseOral | Solco Healthcare US, LLC | 43547-380 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Solco Healthcare US, LLC | 43547-381 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1964 |