Prescription drug · ANDA
Duloxetine (duloxetine hydrochloride) NDC 82009-029
Duloxetine hydrochloride 20 mg/1 · Capsule, Delayed release pellets · Oral · Quallent Pharmaceuticals Health, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-029-05 | 82009002905 | 500 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82009-029-05)Marketed from Dec 15, 2022 |
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 hydrochloride
- Active ingredients
- Duloxetine hydrochloride — 20 mg/1
- Dosage form
- Capsule, Delayed release pellets
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203088
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 82009-029_c7833be1-34d9-43e4-8aff-966c14aa2798SPL ID c7833be1-34d9-43e4-8aff-966c14aa2798SPL set ID 31362045-201f-45f3-99f2-a5e322a0c30bRxCUI 596926, 596930, 596934, 616402UNII 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
N482009002905followed by a unit qualifier and the quantityPackage 82009-0029-05. 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 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 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203088
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 Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 71335-0392 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-747 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-746 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-748 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-750 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Proficient Rx LP | 63187-720 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Proficient Rx LP | 63187-735 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 71335-0509 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 63629-9187 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-218 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Golden State Medical Supply, Inc. | 51407-819 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Golden State Medical Supply, Inc. | 51407-817 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Golden State Medical Supply, Inc. | 51407-818 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Proficient Rx LP | 63187-702 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | A-S Medication Solutions | 50090-6889 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1597 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1598 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Proficient Rx LP | 82804-024 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1599 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1600 |
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