Prescription drug · ANDA
Duloxetine NDC 68071-5340
Duloxetine hydrochloride 30 mg/1 · Capsule, Delayed release · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)68071-5340Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-5340Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-5340-9 | 6807153400968071534009 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-5340-9)Marketed from Oct 13, 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 — 30 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090694
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-5340_5dc00610-881a-ff10-e063-6394a90a8590SPL ID 5dc00610-881a-ff10-e063-6394a90a8590
- 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
N468071534009followed by a unit qualifier and the quantityPackage 68071-5340-09. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 68071-5340
- What is NDC 68071-5340?
- 68071-5340 is the product NDC for Duloxetine, Duloxetine hydrochloride 30 mg/1 capsule, delayed release, listed with the FDA by NuCare Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Duloxetine.
- What is the active ingredient?
- Duloxetine hydrochloride.
- Who is the labeler?
- NuCare Pharmaceuticals, Inc., NDC labeler code 68071. 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 090694
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 20 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-2624 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-2625 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0441 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | REMEDYREPACK INC. | 70518-1244 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-3163 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-7784 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8608 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Preferred Pharmaceuticals Inc. | 68788-8623 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-807 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-808 |
| Duloxetine | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-809 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Golden State Medical Supply, Inc. | 51407-810 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Coupler LLC | 67046-1585 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | A-S Medication Solutions | 50090-6281 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Coupler LLC | 67046-1598 |
| Duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Lupin Pharmaceuticals, Inc. | 68180-294 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Lupin Pharmaceuticals, Inc. | 68180-295 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Lupin Pharmaceuticals, Inc. | 68180-296 |
| Duloxetine | Duloxetine hydrochloride 40 mg/1 | Capsule, Delayed releaseOral | Lupin Pharmaceuticals, Inc. | 68180-297 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3775 |
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