Prescription drug · ANDA

Duloxetine NDC 68788-4025

Duloxetine hydrochloride 30 mg/1 · Capsule, Delayed release pellets · Oral · Preferred Phamaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-4025Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-4025Add 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
68788-4025-36878840250330 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4025-3)Marketed from Sep 15, 2025
68788-4025-66878840250660 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4025-6)Marketed from Sep 15, 2025
68788-4025-96878840250990 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4025-9)Marketed from Sep 15, 2025

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
Generic name (nonproprietary)
duloxetine
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 090776
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68788-4025_c5aac428-d929-4688-a9d5-4e9314aa62ccSPL ID c5aac428-d929-4688-a9d5-4e9314aa62ccSPL set ID c5aac428-d929-4688-a9d5-4e9314aa62ccRxCUI 596930, 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

N468788402503 followed by a unit qualifier and the quantity

Package 68788-4025-03. 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 . 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 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 neuropathi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090776

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

FDA NDC Directory listings under ANDA 090776
ProductStrengthForm · routeLabelerProduct NDC
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralHAWAII REPACK, INC85534-0050
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralHAWAII REPACK, INC85534-0051
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack63629-8748
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack71335-1445
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralActavis Pharma, Inc.0228-2890
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralActavis Pharma, Inc.0228-2891
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralActavis Pharma, Inc.0228-2892
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralPreferred Phamaceuticals Inc.68788-4026
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralAsclemed USA, Inc.76420-236
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1058
Duloxetine HCL DRduloxetine hclDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralAdvanced Rx of Tennessee, LLC80425-0086
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralHAWAII REPACK, INC85534-0017
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralNuCare Pharmaceuticals,Inc.68071-3779
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralProficient Rx LP71205-525

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Duloxetine NDC 68788-4025 | Med-Code