Prescription drug · ANDA
duloxetine NDC 70247-014
Duloxetine hydrochloride 60 mg/1 · Capsule, Delayed release · Oral · Qingdao BAHEAL Pharmaceutical Co., Ltd.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70247-014-03 | 70247001403 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-014-03)Marketed from May 8, 2018 | |
| 70247-014-06 | 70247001406 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-014-06)Marketed from May 8, 2018 | |
| 70247-014-50 | 70247001450 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-014-50)Marketed from May 8, 2018 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210599
- Marketing start
- Listing expires
- Other FDA classes
- Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 70247-014_435c56f7-5995-3906-e063-6394a90af073SPL ID 435c56f7-5995-3906-e063-6394a90af073SPL set ID e428429e-e1ea-40e1-870f-134533dc3aa1RxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0370247013034, 0370247014031, 0370247014062, 0370247012068, 0370247014505, 0370247013096, 0370247013102
- 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
N470247001403followed by a unit qualifier and the quantityPackage 70247-0014-03. 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 • 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. Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210599
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 30 mg/1 | Capsule, Delayed releaseOral | Qingdao BAHEAL Pharmaceutical Co., Ltd. | 70247-013 |
| duloxetine | Duloxetine hydrochloride 20 mg/1 | Capsule, Delayed releaseOral | Qingdao BAHEAL Pharmaceutical Co., Ltd. | 70247-012 |