Prescription drug · ANDA
Duloxetine (Duloxetine hydrochloride) NDC 71610-401
Duloxetine hydrochloride 20 mg/1 · Capsule, Delayed release · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-401-83 | 7161004018371610040183 | 3600 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-401-83)Marketed from Feb 26, 2020 |
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
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090778
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 71610-401_157fe8e5-a477-47eb-adac-6b9ffe571af9SPL ID 157fe8e5-a477-47eb-adac-6b9ffe571af9SPL set ID b102b8e6-d58f-419c-bb35-720bafa13294RxCUI 596926, 596930UNII 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
N471610040183followed by a unit qualifier and the quantityPackage 71610-0401-83. 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 [ see Clinical Studies (14.1 )] Generalized Anxiety Disorder [ see Clinical Studies (14.2)] Diabetic Peripheral Neuropathy [ see Clinical Studies (14.3)] Chronic Musculoskeletal Pain [ see Clinical Studies (14.5)] Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1 ) Generalized Anxiety Disorder (GAD) ( 1 ) Diabetic Peripheral Neuropathic Pain (DPNP) ( 1 ) Chronic Musculoskeletal Pain ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71610-401
- What is NDC 71610-401?
- 71610-401 is the product NDC for Duloxetine (duloxetine hydrochloride), Duloxetine hydrochloride 20 mg/1 capsule, delayed release, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Duloxetine (Duloxetine Hydrochloride).
- What is the active ingredient?
- Duloxetine hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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?
- 140 other product NDCs are listed under this name. See all Duloxetine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Duloxetine 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 | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | ANI Pharmaceuticals, Inc. | 70954-860 | 70954-0860-30 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | ANI Pharmaceuticals, Inc. | 70954-861 | 70954-0861-20 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | ANI Pharmaceuticals, Inc. | 70954-864 | 70954-0864-20 |
| Duloxetine | Duloxetine hydrochloride 120 mg/1 | Capsule, Delayed releaseOral | Almatica Pharma LLC | 52427-791 | 52427-0791-30 |
| Duloxetine | Duloxetine hydrochloride 80 mg/1 | Capsule, Delayed releaseOral | Almatica Pharma LLC | 52427-821 | 52427-0821-30 |
| Duloxetine | Duloxetine hydrochloride 90 mg/1 | Capsule, Delayed releaseOral | Almatica Pharma LLC | 52427-913 | 52427-0913-30 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-4128 | 68788-4128-0368788-4128-0668788-4128-09 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Coupler LLC | 67046-1598 | 67046-1598-03 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Coupler LLC | 67046-1585 | 67046-1585-03 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed release pelletsOral | Preferred Phamaceuticals Inc. | 68788-4025 | 68788-4025-0368788-4025-0668788-4025-09 |
Other NDCs under ANDA 090778
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 |
|---|---|---|---|---|
| Duloxetineduloxetine hydrochloride | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Aurobindo Pharma Limited | 59651-279 |
| Duloxetineduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-612 |
| Duloxetineduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 63187-666 |
| Duloxetineduloxetine hydrochloride | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-402 |
| Duloxetine HCL DRduloxetine hcl | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0014 |