Prescription drug · ANDA
Duloxetine NDC 47335-381
Duloxetine hydrochloride 20 mg/1 · Capsule, Delayed release · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 47335-381-08 | 47335038108 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-08)Marketed from Dec 11, 2013 | |
| 47335-381-18 | 47335038118 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-18)Marketed from Dec 11, 2013 | |
| 47335-381-61 | 47335038161 | 100 BLISTER PACK in 1 CARTON (47335-381-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Dec 11, 2013 | |
| 47335-381-83 | 47335038183 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-83)Marketed from Dec 11, 2013 | |
| 47335-381-86 | 47335038186 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-86)Marketed from Dec 11, 2013 | |
| 47335-381-88 | 47335038188 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-381-88)Marketed from Dec 11, 2013 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090745
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 47335-381_cec0154d-5c8c-496d-89bd-ba2a93aee774SPL ID cec0154d-5c8c-496d-89bd-ba2a93aee774SPL set ID f16beb64-5878-486a-82ee-8e83e728f26cRxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0347335383836, 0347335382839
- 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
N447335038108followed by a unit qualifier and the quantityPackage 47335-0381-08. 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 USP 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 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. Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the foll…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090745
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 60 mg/1 | Capsule, Delayed releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-383 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Sun Pharmaceutical Industries, Inc. | 47335-382 |