NDC codes

FDA NDC Directory
Product NDC (as listed)82804-024Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82804-0024Add 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
82804-024-30828040024308280400243030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-30)Marketed from Oct 16, 2023
82804-024-60828040024608280400246060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-60)Marketed from Oct 16, 2023
82804-024-90828040024908280400249090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (82804-024-90)Marketed from Oct 16, 2023

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 Delayed-ReleaseSuffix: Delayed-Release
Generic name (nonproprietary)
duloxetine hydrochloride
Active ingredients
Duloxetine hydrochloride — 40 mg/1
Dosage form
Capsule, Delayed release pellets
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 82804
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 82804-024_f5e7503a-b28f-4cd0-a4ee-47bdca88d54bSPL ID f5e7503a-b28f-4cd0-a4ee-47bdca88d54bSPL set ID f5e7503a-b28f-4cd0-a4ee-47bdca88d54bRxCUI 616402UNII 9044SC542WUPC 0382804024308

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

N482804002430 followed by a unit qualifier and the quantity

Package 82804-0024-30. 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 the…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82804-024

What is NDC 82804-024?
82804-024 is the product NDC for Duloxetine Delayed-Release (duloxetine hydrochloride), Duloxetine hydrochloride 40 mg/1 capsule, delayed release pellets, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Duloxetine Delayed-Release (Duloxetine hydrochloride).
What is the active ingredient?
Duloxetine hydrochloride.
Who is the labeler?
Proficient Rx LP, NDC labeler code 82804. 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 Delayed-Release?
32 other product NDCs are listed under this name. See all Duloxetine Delayed-Release 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 Delayed-Release NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralPreferred Pharmaceuticals Inc.68788-836268788-8362-0068788-8362-0368788-8362-09
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralPreferred Pharmaceuticals Inc.68788-789768788-7897-0368788-7897-0668788-7897-09
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBreckenridge Pharmaceutical, Inc.51991-75051991-0750-0551991-0750-1051991-0750-33+1 more
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack63629-206363629-2063-01
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack63629-918763629-9187-01
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBluePoint Laboratories68001-36868001-0368-04
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-160072162-1600-03
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralREMEDYREPACK INC.70518-012270518-0122-05
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralA-S Medication Solutions50090-688950090-6889-0050090-6889-01
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralGolden State Medical Supply, Inc.51407-81751407-0817-60

All 33 Duloxetine Delayed-Release NDCs

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 20 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1597
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1600
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1598
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1599
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack71335-0165
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralBreckenridge Pharmaceutical, Inc.51991-746
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralBreckenridge Pharmaceutical, Inc.51991-747
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
Duloxetineduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralQuallent Pharmaceuticals Health, LLC82009-032
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralAphena Pharma Solutions - Tennessee, LLC71610-736
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralProficient Rx LP63187-702
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralAphena Pharma Solutions - Tennessee, LLC71610-739
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralAphena Pharma Solutions - Tennessee, LLC71610-743
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 20 mg/1Capsule, Delayed release pelletsOralA-S Medication Solutions50090-6889
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack63629-9187
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack71335-0392
Duloxetineduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralQuallent Pharmaceuticals Health, LLC82009-031

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