Prescription drug · ANDA
Duloxetine NDC 71205-525
Duloxetine hydrochloride 20 mg/1 · Capsule, Delayed release pellets · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-525-30 | 71205052530 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-525-30)Marketed from Jan 22, 2021 | |
| 71205-525-60 | 71205052560 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-525-60)Marketed from Jan 22, 2021 | |
| 71205-525-90 | 71205052590 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71205-525-90)Marketed from Jan 22, 2021 |
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 pellets
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090776
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71205-525_4318dfda-092c-4ade-83c5-581bc968f391SPL ID 4318dfda-092c-4ade-83c5-581bc968f391SPL set ID 3dec1805-9a95-462e-8784-303004d500b1RxCUI 596926UNII 9044SC542WUPC 0371205525309
- 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
N471205052530followed by a unit qualifier and the quantityPackage 71205-0525-30. 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 • 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 090776
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 20 mg/1 | Capsule, Delayed release pelletsOral | HAWAII REPACK, INC | 85534-0050 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | HAWAII REPACK, INC | 85534-0051 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 63629-8748 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 71335-1445 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Actavis Pharma, Inc. | 0228-2890 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Actavis Pharma, Inc. | 0228-2891 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Actavis Pharma, Inc. | 0228-2892 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Preferred Phamaceuticals Inc. | 68788-4025 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Preferred Phamaceuticals Inc. | 68788-4026 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Asclemed USA, Inc. | 76420-236 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1058 |
| Duloxetine HCL DRduloxetine hcl | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Advanced Rx of Tennessee, LLC | 80425-0086 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | HAWAII REPACK, INC | 85534-0017 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | NuCare Pharmaceuticals,Inc. | 68071-3779 |