NDC codes

FDA NDC Directory
Product NDC (as listed)71335-0392Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-0392Add 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 NDC11-digit (billing)PackageCopy
71335-0392-17133503920130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-1)Marketed from Mar 12, 2018
71335-0392-27133503920260 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-2)Marketed from Mar 22, 2018
71335-0392-37133503920328 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-3)Marketed from May 29, 2024
71335-0392-4713350392046 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-4)Marketed from Nov 8, 2018
71335-0392-57133503920590 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-5)Marketed from Mar 27, 2018
71335-0392-67133503920615 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-6)Marketed from Feb 18, 2019
71335-0392-771335039207180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-7)Marketed from Jul 23, 2019
71335-0392-871335039208120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-0392-8)Marketed from May 29, 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 Delayed-ReleaseSuffix: Delayed-Release
Generic name (nonproprietary)
duloxetine hydrochloride
Active ingredients
Duloxetine hydrochloride — 30 mg/1
Dosage form
Capsule, Delayed release pellets
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203088
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 71335-0392_e8fe3c0e-a41b-4e12-a4c7-71c8f6e37de5SPL ID e8fe3c0e-a41b-4e12-a4c7-71c8f6e37de5SPL set ID 41876761-9d5b-4190-a200-6a822c54582eRxCUI 596930UNII 9044SC542W

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

N471335039201 followed by a unit qualifier and the quantity

Package 71335-0392-01. 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 delayed-release capsules 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 are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203088

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

FDA NDC Directory listings under ANDA 203088
ProductStrengthForm · routeLabelerProduct NDC
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralBreckenridge Pharmaceutical, Inc.51991-747
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralBreckenridge Pharmaceutical, Inc.51991-746
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralBreckenridge Pharmaceutical, Inc.51991-748
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBreckenridge Pharmaceutical, Inc.51991-750
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralProficient Rx LP63187-720
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralProficient Rx LP63187-735
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack71335-0509
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack63629-9187
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralAphena Pharma Solutions - Tennessee, LLC71610-218
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralGolden State Medical Supply, Inc.51407-819
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralGolden State Medical Supply, Inc.51407-817
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralGolden State Medical Supply, Inc.51407-818
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralProficient Rx LP63187-702
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralA-S Medication Solutions50090-6889
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1597
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1598
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralProficient Rx LP82804-024
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1599
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1600
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralPreferred Pharmaceuticals Inc.68788-8362

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