duloxetine NDC 70247-013

NDC codes

FDA NDC Directory

Product NDC (as listed)70247-013Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70247-0013Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
70247-013-03	70247001303	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-03)Marketed from May 8, 2018
70247-013-09	70247001309	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-09)Marketed from May 8, 2018
70247-013-10	70247001310	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70247-013-10)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 — 30 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Qingdao BAHEAL Pharmaceutical Co., Ltd.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210599
Marketing start: May 5, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 70247-013_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

N470247001303 followed by a unit qualifier and the quantity

Package 70247-0013-03. 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 Nov 11, 2025. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210599

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210599
Product	Strength	Form · route	Labeler	Product NDC
duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Qingdao BAHEAL Pharmaceutical Co., Ltd.	70247-012
duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	Qingdao BAHEAL Pharmaceutical Co., Ltd.	70247-014