Prescription drug · NDA
Drizalma Sprinkle (duloxetine) NDC 47335-619
Duloxetine hydrochloride 60 mg/1 · Capsule, Delayed release · Oral · SUN PHARMACEUTICAL INDUSTRIES, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-619-10 | 47335061910 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-10)Marketed from Jun 10, 2024 | |
| 47335-619-30 | 47335061930 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-30)Marketed from Jun 10, 2024 | |
| 47335-619-60 | 47335061960 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-60)Marketed from Jun 10, 2024 | |
| 47335-619-90 | 47335061990 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-619-90)Marketed from Jun 10, 2024 |
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)
- Drizalma Sprinkle
- Generic name (nonproprietary)
- duloxetine
- Active ingredients
- Duloxetine hydrochloride — 60 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212516
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 47335-619_67134e3c-1819-4262-a36f-460afdbb165dSPL ID 67134e3c-1819-4262-a36f-460afdbb165dSPL set ID b41423b8-dfec-4d79-ba3c-e43a87803d85RxCUI 2200168, 2200174, 2200175, 2200177, 2200178, 2200180, 2200181, 2200183UNII 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
N447335061910followed by a unit qualifier and the quantityPackage 47335-0619-10. 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)
DRIZALMA SPRINKLE is 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 Neuropathy in adults • Fibromyalgia in adults • Chronic Musculoskeletal Pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine delayed-release capsules). However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. DRIZALMA SPRINKLE is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of following conditions: • Major …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 212516
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 |
|---|---|---|---|---|
| Drizalma Sprinkleduloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | SUN PHARMACEUTICAL INDUSTRIES, INC. | 47335-616 |
| Drizalma Sprinkleduloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | SUN PHARMACEUTICAL INDUSTRIES, INC. | 47335-617 |
| Drizalma Sprinkleduloxetine | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed releaseOral | SUN PHARMACEUTICAL INDUSTRIES, INC. | 47335-618 |