Prescription drug · NDA
Duloxetine NDC 52427-821
Duloxetine hydrochloride 80 mg/1 · Capsule, Delayed release · Oral · Almatica Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52427-821-30 | 52427082130 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (52427-821-30)Marketed from Jul 1, 2026 |
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 — 80 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Almatica Pharma LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219131
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 52427-821_928a297f-2836-28d7-c820-ece5656c6b57SPL ID 928a297f-2836-28d7-c820-ece5656c6b57SPL set ID bb2ca3bf-983c-1e4a-a91d-dc7dee66d741RxCUI 2745865, 2745867, 2745869UNII 9044SC542WUPC 0352427791307, 0352427821301, 0352427913303
- 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
N452427082130followed by a unit qualifier and the quantityPackage 52427-0821-30. 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 Duloxetine Delayed-Release Capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 219131
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 120 mg/1 | Capsule, Delayed releaseOral | Almatica Pharma LLC | 52427-791 |
| Duloxetine | Duloxetine hydrochloride 90 mg/1 | Capsule, Delayed releaseOral | Almatica Pharma LLC | 52427-913 |