Prescription drug · ANDA
Duloxetine Delayed-Release (Duloxetine hydrochloride) NDC 82804-024
Duloxetine hydrochloride 40 mg/1 · Capsule, Delayed release pellets · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-024-30 | 8280400243082804002430 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-30)Marketed from Oct 16, 2023 | |
| 82804-024-60 | 8280400246082804002460 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-60)Marketed from Oct 16, 2023 | |
| 82804-024-90 | 8280400249082804002490 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-90)Marketed from Oct 16, 2023 |
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 Delayed-ReleaseSuffix: Delayed-Release
- Generic name (nonproprietary)
- duloxetine hydrochloride
- Active ingredients
- Duloxetine hydrochloride — 40 mg/1
- Dosage form
- Capsule, Delayed release pellets
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- 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 82804-024_f5e7503a-b28f-4cd0-a4ee-47bdca88d54bSPL ID f5e7503a-b28f-4cd0-a4ee-47bdca88d54bSPL set ID f5e7503a-b28f-4cd0-a4ee-47bdca88d54bRxCUI 616402UNII 9044SC542WUPC 0382804024308
- 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
N482804002430followed by a unit qualifier and the quantityPackage 82804-0024-30. 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 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 delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the…
Excerpt only. Read the full label for complete information.
About NDC 82804-024
- What is NDC 82804-024?
- 82804-024 is the product NDC for Duloxetine Delayed-Release (duloxetine hydrochloride), Duloxetine hydrochloride 40 mg/1 capsule, delayed release pellets, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Duloxetine Delayed-Release (Duloxetine hydrochloride).
- What is the active ingredient?
- Duloxetine hydrochloride.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Duloxetine Delayed-Release?
- 32 other product NDCs are listed under this name. See all Duloxetine Delayed-Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Duloxetine Delayed-Release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Preferred Pharmaceuticals Inc. | 68788-8362 | 68788-8362-0068788-8362-0368788-8362-09 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Preferred Pharmaceuticals Inc. | 68788-7897 | 68788-7897-0368788-7897-0668788-7897-09 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-750 | 51991-0750-0551991-0750-1051991-0750-33+1 more |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 63629-2063 | 63629-2063-01 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 63629-9187 | 63629-9187-01 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | BluePoint Laboratories | 68001-368 | 68001-0368-04 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1600 | 72162-1600-03 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | REMEDYREPACK INC. | 70518-0122 | 70518-0122-05 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | A-S Medication Solutions | 50090-6889 | 50090-6889-0050090-6889-01 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Golden State Medical Supply, Inc. | 51407-817 | 51407-0817-60 |
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 20 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1597 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1600 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1598 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 72162-1599 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Bryant Ranch Prepack | 71335-0165 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-746 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Breckenridge Pharmaceutical, Inc. | 51991-747 |
| 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 |
| Duloxetineduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Quallent Pharmaceuticals Health, LLC | 82009-032 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-736 |
| 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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-739 |
| Duloxetine Delayed-Releaseduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed release pelletsOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-743 |
| 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 20 mg/1 | Capsule, Delayed release pelletsOral | A-S Medication Solutions | 50090-6889 |
| 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 | Bryant Ranch Prepack | 71335-0392 |
| Duloxetineduloxetine hydrochloride | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed release pelletsOral | Quallent Pharmaceuticals Health, LLC | 82009-031 |
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