Prescription drug · ANDA
Duloxetine Hydrochloride NDC 33342-161
Duloxetine hydrochloride 30 mg/1 · Capsule, Delayed release · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-161-07 | 33342016107 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-07)Marketed from Mar 24, 2017 | |
| 33342-161-10 | 33342016110 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-10)Marketed from Mar 24, 2017 | |
| 33342-161-12 | 33342016112 | 10 BLISTER PACK in 1 CARTON (33342-161-12) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Mar 24, 2017 | |
| 33342-161-44 | 33342016144 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-44)Marketed from Mar 24, 2017 |
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 Hydrochloride
- Generic name (nonproprietary)
- duloxetine hydrochloride
- Active ingredients
- Duloxetine hydrochloride — 30 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204815
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 33342-161_d2bdee38-c510-432f-bf05-a8a573cf459cSPL ID d2bdee38-c510-432f-bf05-a8a573cf459cSPL set ID 177ce798-3924-416b-ba37-23dfa911a43bRxCUI 596926, 596930, 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
N433342016107followed by a unit qualifier and the quantityPackage 33342-0161-07. 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 • Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are 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 ( 1 ) • Fibromyalgia (FM)…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204815
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 Hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-160 |
| Duloxetine Hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Macleods Pharmaceuticals Limited | 33342-162 |