Prescription drug · ANDA
Duloxetine NDC 71335-0402
Duloxetine hydrochloride 60 mg/1 · Capsule, Delayed release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0402-1 | 71335040201 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-1)Marketed from Mar 2, 2018 | |
| 71335-0402-2 | 71335040202 | 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-2)Marketed from Dec 27, 2021 | |
| 71335-0402-3 | 71335040203 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-3)Marketed from Apr 11, 2018 | |
| 71335-0402-4 | 71335040204 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-4)Marketed from Oct 30, 2018 | |
| 71335-0402-5 | 71335040205 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-5)Marketed from Nov 12, 2018 | |
| 71335-0402-6 | 71335040206 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0402-6)Marketed from Dec 27, 2021 |
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 — 60 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 71335-0402_fffa451d-800b-4e92-a01c-5a174e6e32b4SPL ID fffa451d-800b-4e92-a01c-5a174e6e32b4SPL set ID b19ba26f-4711-443e-83cf-5af7bb43a0a0RxCUI 596934UNII 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
N471335040201followed by a unit qualifier and the quantityPackage 71335-0402-01. 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 treatment…
Excerpt only. Read the full label for complete information.
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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