What is NDC 47335-383?

47335-383 is the product NDC for Duloxetine, Duloxetine hydrochloride 60 mg/1 capsule, delayed release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Duloxetine?

140 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Duloxetine NDC 47335-383 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-383Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0383Add 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
47335-383-08	4733503830847335038308	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-08)Marketed from Dec 11, 2013
47335-383-18	4733503831847335038318	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-18)Marketed from Dec 11, 2013
47335-383-61	4733503836147335038361	100 BLISTER PACK in 1 CARTON (47335-383-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Dec 11, 2013
47335-383-83	4733503838347335038383	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-83)Marketed from Dec 11, 2013
47335-383-88	4733503838847335038388	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-383-88)Marketed from Dec 11, 2013

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
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090745
Marketing start: Dec 11, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 47335-383_cec0154d-5c8c-496d-89bd-ba2a93aee774SPL ID cec0154d-5c8c-496d-89bd-ba2a93aee774SPL set ID f16beb64-5878-486a-82ee-8e83e728f26cRxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0347335383836, 0347335382839
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

N447335038308 followed by a unit qualifier and the quantity

Package 47335-0383-08. 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 8, 2021. This label includes a boxed warning.

Indications (excerpt from the label)

Duloxetine delayed-release capsules USP 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 is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the foll…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-383

What is NDC 47335-383?: 47335-383 is the product NDC for Duloxetine, Duloxetine hydrochloride 60 mg/1 capsule, delayed release, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 5 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Duloxetine.
What is the active ingredient?: Duloxetine hydrochloride.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Duloxetine?: 140 other product NDCs are listed under this name. See all Duloxetine NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Duloxetine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	ANI Pharmaceuticals, Inc.	70954-860	70954-0860-30
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	ANI Pharmaceuticals, Inc.	70954-861	70954-0861-20
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	ANI Pharmaceuticals, Inc.	70954-864	70954-0864-20
Duloxetine	Duloxetine hydrochloride 120 mg/1	Capsule, Delayed releaseOral	Almatica Pharma LLC	52427-791	52427-0791-30
Duloxetine	Duloxetine hydrochloride 80 mg/1	Capsule, Delayed releaseOral	Almatica Pharma LLC	52427-821	52427-0821-30
Duloxetine	Duloxetine hydrochloride 90 mg/1	Capsule, Delayed releaseOral	Almatica Pharma LLC	52427-913	52427-0913-30
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-4128	68788-4128-0368788-4128-0668788-4128-09
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	Coupler LLC	67046-1598	67046-1598-03
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	Coupler LLC	67046-1585	67046-1585-03
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed release pelletsOral	Preferred Phamaceuticals Inc.	68788-4025	68788-4025-0368788-4025-0668788-4025-09

All 141 Duloxetine NDCs

Other NDCs under ANDA 090745

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

FDA NDC Directory listings under ANDA 090745
Product	Strength	Form · route	Labeler	Product NDC
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Sun Pharmaceutical Industries, Inc.	47335-381
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	Sun Pharmaceutical Industries, Inc.	47335-382