Prescription drug · ANDA
Duloxetine NDC 85534-0016
Duloxetine hydrochloride 20 mg/1 · Capsule, Delayed release · Oral · HAWAII REPACK, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85534-0016-0 | 85534001600 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0016-0)Marketed from Jul 2, 2026 | |
| 85534-0016-1 | 85534001601 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0016-1)Marketed from Jul 2, 2026 | |
| 85534-0016-2 | 85534001602 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0016-2)Marketed from Jul 2, 2026 | |
| 85534-0016-3 | 85534001603 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (85534-0016-3)Marketed from Jul 2, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Route
- Oral
- Labeler
- HAWAII REPACK, INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208706
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 85534-0016_5b063723-7f0a-3541-e063-6294a90ad207SPL ID 5b063723-7f0a-3541-e063-6294a90ad207SPL set ID 79bfd6be-a1ff-4786-b4e2-abbd0a3e3932RxCUI 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
N485534001600followed by a unit qualifier and the quantityPackage 85534-0016-00. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 208706
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 60 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-623 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 71205-602 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 71205-005 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-633 |
| Duloxetine D/R | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Direct_Rx | 72189-661 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-634 |
| Duloxetine | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed releaseOral | Asclemed USA, Inc. | 76420-636 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-5940 |
| Duloxetine | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed releaseOral | Ajanta Pharma USA Inc. | 27241-164 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-338 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | St. Mary's Medical Park Pharmacy | 60760-759 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-1011 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-1054 |
| Duloxetine | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed releaseOral | BluePoint Laboratories | 68001-570 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-1139 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-3287 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | BluePoint Laboratories | 68001-596 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | BluePoint Laboratories | 68001-594 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | BluePoint Laboratories | 68001-595 |
| Duloxetine | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed releaseOral | Quallent Pharmaceuticals Health LLC | 82009-172 |
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