Prescription drug · ANDA
Duloxetine (Duloxetine hydrochloride) NDC 25000-608
Duloxetine hydrochloride 20 mg/1 · Capsule, Delayed release · Oral · MARKSANS PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25000-608-06 | 2500006080625000060806 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-608-06)Marketed from May 27, 2022 |
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
- MARKSANS PHARMA LIMITEDNDC labeler code 25000
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090723
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 25000-608_c8aa863f-eb1f-4b66-9ec6-2af2c7958248SPL ID c8aa863f-eb1f-4b66-9ec6-2af2c7958248SPL set ID 3686cde5-f76d-4d16-aa5d-caceb8408f8cRxCUI 596926, 596930, 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
N425000060806followed by a unit qualifier and the quantityPackage 25000-0608-06. 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 and pediatric patients 13 years of age and older • Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: • Major depressive disorder (MDD) in adults (1) • Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older (1) • Diabetic peripheral neuropathic pa…
Excerpt only. Read the full label for complete information.
About NDC 25000-608
- What is NDC 25000-608?
- 25000-608 is the product NDC for Duloxetine (duloxetine hydrochloride), Duloxetine hydrochloride 20 mg/1 capsule, delayed release, listed with the FDA by MARKSANS PHARMA LIMITED. 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?
- MARKSANS PHARMA LIMITED, NDC labeler code 25000. 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 090723
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 30 mg/1 | Capsule, Delayed releaseOral | MARKSANS PHARMA LIMITED | 25000-609 |
| Duloxetineduloxetine hydrochloride | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | MARKSANS PHARMA LIMITED | 25000-610 |