Prescription drug · ANDA
Duloxetine NDC 71335-1672
Duloxetine hydrochloride 30 mg/1 · Capsule, Delayed release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1672-1 | 71335167201 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-1)Marketed from Jul 27, 2020 | |
| 71335-1672-2 | 71335167202 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-2)Marketed from Aug 28, 2020 | |
| 71335-1672-3 | 71335167203 | 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-3)Marketed from Apr 4, 2024 | |
| 71335-1672-4 | 71335167204 | 6 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-4)Marketed from Apr 4, 2024 | |
| 71335-1672-5 | 71335167205 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-5)Marketed from Dec 22, 2020 | |
| 71335-1672-6 | 71335167206 | 15 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-6)Marketed from Jan 7, 2021 | |
| 71335-1672-7 | 71335167207 | 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-7)Marketed from Feb 1, 2021 | |
| 71335-1672-8 | 71335167208 | 120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-8)Marketed from Apr 4, 2024 |
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
- Bryant Ranch Prepack
- 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 71335-1672_a5fa1183-35f7-41b9-8452-5d00ccd868a3SPL ID a5fa1183-35f7-41b9-8452-5d00ccd868a3SPL set ID c52fc4ad-7bda-4824-8edf-117d3d8d6b3dRxCUI 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
N471335167201followed by a unit qualifier and the quantityPackage 71335-1672-01. 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 | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | Ascend Laboratories, LLC | 67877-265 |
| 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 |