Prescription drug · NDA
Cymbalta (duloxetine hydrochloride) NDC 0002-3270
Duloxetine hydrochloride 60 mg/1 · Capsule, Delayed release · Oral · Eli Lilly and Company
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Cymbalta
- Generic name (nonproprietary)
- duloxetine hydrochloride
- Active ingredients
- Duloxetine hydrochloride — 60 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Eli Lilly and Company
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021427
- Marketing start
- Marketing end
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0002-3270_aa5061b1-f237-425a-9d05-575c333dfd37SPL ID aa5061b1-f237-425a-9d05-575c333dfd37SPL set ID 2f7d4d67-10c1-4bf4-a7f2-c185fbad64baRxCUI 596926, 596928, 596930, 596932, 596934, 615186UNII 9044SC542WUPC 0300023270306, 0300023240309, 0300023235602
- 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.
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
CYMBALTA ® 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 neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults CYMBALTA ® 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 ( 1 ) Fibromyalgia (FM) in adults and pediat…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021427
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 |
|---|---|---|---|---|
| Cymbaltaduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Eli Lilly and Company | 0002-3235 |
| Cymbaltaduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Eli Lilly and Company | 0002-3240 |