Prescription drug · ANDA
Duloxetine NDC 70954-860
Duloxetine hydrochloride 20 mg/1 · Capsule, Delayed release · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-860-30 | 70954086030 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70954-860-30)Marketed from Jul 13, 2026 |
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 — 20 mg/1
- Dosage form
- Capsule, Delayed release
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202336
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 70954-860_e2cf5f3b-563e-4ed1-bcf4-19aadc3fe210SPL ID e2cf5f3b-563e-4ed1-bcf4-19aadc3fe210SPL set ID fb37745f-fb40-4f7f-8143-ea1874c38e1bRxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0370954864202, 0370954860303, 0370954861201
- 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
N470954086030followed by a unit qualifier and the quantityPackage 70954-0860-30. 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 delayed-release capsules 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) i…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202336
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 60 mg/1 | Capsule, Delayed releaseOral | Inventia Healthcare Limited. | 49252-009 |
| duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Inventia Healthcare Limited. | 49252-007 |
| duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | Inventia Healthcare Limited. | 49252-008 |
| Duloxetine | Duloxetine hydrochloride 30 mg/1 | Capsule, Delayed releaseOral | ANI Pharmaceuticals, Inc. | 70954-861 |
| Duloxetine | Duloxetine hydrochloride 60 mg/1 | Capsule, Delayed releaseOral | ANI Pharmaceuticals, Inc. | 70954-864 |