Prescription drug · ANDA

Duloxetine DR (duloxetine) NDC 80425-0119

Duloxetine hydrochloride 60 mg/1 · Capsule, Delayed release · Oral · Advanced Rx Pharmacy of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0119Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0119Add 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
80425-0119-18042501190130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0119-1)Marketed from Mar 16, 2017
80425-0119-28042501190260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0119-2)Marketed from Mar 16, 2017
80425-0119-38042501190330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0119-3)Marketed from Mar 30, 2023

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 DRSuffix: DR
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 208706
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 80425-0119_2a99a7f4-89e2-19db-e063-6294a90a90daSPL ID 2a99a7f4-89e2-19db-e063-6294a90a90daSPL set ID b70035d4-5a3f-c5b5-e053-2995a90acac1RxCUI 596934UNII 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

N480425011901 followed by a unit qualifier and the quantity

Package 80425-0119-01. 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)

1. Indications and Usage Section 1 INDICATIONS AND USAGE 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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 208706

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

FDA NDC Directory listings under ANDA 208706
ProductStrengthForm · routeLabelerProduct NDC
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-623
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralProficient Rx LP71205-602
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralProficient Rx LP71205-005
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-633
Duloxetine D/RDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralDirect_Rx72189-661
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-634
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-636
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-5940
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralAjanta Pharma USA Inc.27241-164
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralPD-Rx Pharmaceuticals, Inc.72789-338
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-759
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-1011
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-1054
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-570
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-1139
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-3287
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-596
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-594
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-595
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralQuallent Pharmaceuticals Health LLC82009-172

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