What is NDC 68788-4026?

68788-4026 is the product NDC for Duloxetine, Duloxetine hydrochloride 60 mg/1 capsule, delayed release pellets, listed with the FDA by Preferred Phamaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Preferred Phamaceuticals Inc., NDC labeler code 68788. 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 68788-4026 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-4026Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-4026Add 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
68788-4026-3	6878840260368788402603	30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4026-3)Marketed from Sep 15, 2025
68788-4026-6	6878840260668788402606	60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4026-6)Marketed from Sep 15, 2025
68788-4026-9	6878840260968788402609	90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (68788-4026-9)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 — 60 mg/1
Dosage form: Capsule, Delayed release pellets
Route: Oral
Labeler: Preferred Phamaceuticals Inc.NDC labeler code 68788
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090776
Marketing start: Sep 15, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 68788-4026_c5aac428-d929-4688-a9d5-4e9314aa62ccSPL ID c5aac428-d929-4688-a9d5-4e9314aa62ccSPL set ID c5aac428-d929-4688-a9d5-4e9314aa62ccRxCUI 596930, 596934UNII 9044SC542W
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

N468788402603 followed by a unit qualifier and the quantity

Package 68788-4026-03. 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 Sep 15, 2025. 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)

About NDC 68788-4026

What is NDC 68788-4026?: 68788-4026 is the product NDC for Duloxetine, Duloxetine hydrochloride 60 mg/1 capsule, delayed release pellets, listed with the FDA by Preferred Phamaceuticals Inc.. It has 3 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?: Preferred Phamaceuticals Inc., NDC labeler code 68788. 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 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
Product	Strength	Form · route	Labeler	Product NDC
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed release pelletsOral	Actavis Pharma, Inc.	0228-2892
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed release pelletsOral	Bryant Ranch Prepack	63629-8748
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed release pelletsOral	NuCare Pharmaceuticals,Inc.	68071-3779
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed release pelletsOral	Preferred Phamaceuticals Inc.	68788-4025
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed release pelletsOral	Proficient Rx LP	71205-525
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed release pelletsOral	Bryant Ranch Prepack	71335-1445
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed release pelletsOral	Bryant Ranch Prepack	72162-1058
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed release pelletsOral	Asclemed USA, Inc.	76420-236
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed release pelletsOral	HAWAII REPACK, INC	85534-0017
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed release pelletsOral	HAWAII REPACK, INC	85534-0050
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed release pelletsOral	HAWAII REPACK, INC	85534-0051
Duloxetine HCL DRduloxetine hcl	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed release pelletsOral	Advanced Rx of Tennessee, LLC	80425-0086