Prescription drug · ANDA
Duloxetine HCL DR (duloxetine hcl) NDC 80425-0012
Duloxetine hydrochloride 30 mg/1 · Capsule, Delayed release · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0012-1 | 80425001201 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0012-1)Marketed from Sep 25, 2020 | |
| 80425-0012-2 | 80425001202 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0012-2)Marketed from Sep 25, 2020 |
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 HCL DRSuffix: DR
- Generic name (nonproprietary)
- duloxetine hcl
- Active ingredients
- Duloxetine hydrochloride — 30 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- 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 80425-0012_2a984d4a-2346-2be3-e063-6294a90ad5d4SPL ID 2a984d4a-2346-2be3-e063-6294a90ad5d4SPL set ID af6f8abd-19ec-69e4-e053-2a95a90ab69eRxCUI 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
N480425001201followed by a unit qualifier and the quantityPackage 80425-0012-01. 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)
Indications and Usage 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 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.
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 | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Ascend Laboratories, LLC | 67877-265 |
| 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 |