Prescription drug · ANDA
Duloxetine NDC 67877-265
Duloxetine hydrochloride 60 mg/1 · Capsule, Delayed release · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-265-01 | 67877026501 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-01)Marketed from May 1, 2012 | |
| 67877-265-10 | 67877026510 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-10)Marketed from May 1, 2012 | |
| 67877-265-30 | 67877026530 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-30)Marketed from May 1, 2012 | |
| 67877-265-90 | 67877026590 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-90)Marketed from May 1, 2012 |
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
- Active ingredients
- Duloxetine hydrochloride — 60 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- Ascend Laboratories, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203197
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 67877-265_958fae45-5e7a-4f8b-80b7-5934222747b5SPL ID 958fae45-5e7a-4f8b-80b7-5934222747b5SPL set ID e6477c41-97a2-45a7-94b5-487aa65199f6RxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0367877263106
- 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
N467877026501followed by a unit qualifier and the quantityPackage 67877-0265-01. 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 is 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 hydrochloride is 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 pain (DPNP) in adults ( 1 ) Fibromyalgia (FM) in adu…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203197
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 | Ascend Laboratories, LLC | 67877-263 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Ascend Laboratories, LLC | 67877-264 |
| Duloxetine HCL DRduloxetine hcl | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Advanced Rx of Tennessee, LLC | 80425-0012 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Proficient Rx LP | 71205-445 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Bryant Ranch Prepack | 71335-1672 |