NDC codes

FDA NDC Directory
Product NDC (as listed)68788-8782Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-8782Add 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
68788-8782-3687888782036878887820330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-3)Marketed from Dec 11, 2024
68788-8782-6687888782066878887820660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-6)Marketed from Dec 11, 2024
68788-8782-9687888782096878887820990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8782-9)Marketed from Dec 11, 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
Generic name (nonproprietary)
duloxetine
Active ingredients
Duloxetine hydrochloride — 40 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Preferred Pharmaceuticals Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090694
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68788-8782_c45d0905-3478-4da4-b114-9f4cfb4a58efSPL ID c45d0905-3478-4da4-b114-9f4cfb4a58efSPL set ID ae381859-be09-43e1-8b56-d0d8f4b49020RxCUI 616402UNII 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

N468788878203 followed by a unit qualifier and the quantity

Package 68788-8782-03. 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 capsule is 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 adults ( 1 ) • Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older ( 1 ) • Chronic musculoskeletal pain in adults ( 1 ) 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 • Di…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-8782

What is NDC 68788-8782?
68788-8782 is the product NDC for Duloxetine, Duloxetine hydrochloride 40 mg/1 capsule, delayed release, listed with the FDA by Preferred Pharmaceuticals 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 Pharmaceuticals 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralANI Pharmaceuticals, Inc.70954-86070954-0860-30
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralANI Pharmaceuticals, Inc.70954-86170954-0861-20
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralANI Pharmaceuticals, Inc.70954-86470954-0864-20
DuloxetineDuloxetine hydrochloride 120 mg/1Capsule, Delayed releaseOralAlmatica Pharma LLC52427-79152427-0791-30
DuloxetineDuloxetine hydrochloride 80 mg/1Capsule, Delayed releaseOralAlmatica Pharma LLC52427-82152427-0821-30
DuloxetineDuloxetine hydrochloride 90 mg/1Capsule, Delayed releaseOralAlmatica Pharma LLC52427-91352427-0913-30
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-412868788-4128-0368788-4128-0668788-4128-09
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralCoupler LLC67046-159867046-1598-03
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralCoupler LLC67046-158567046-1585-03
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralPreferred Phamaceuticals Inc.68788-402568788-4025-0368788-4025-0668788-4025-09

All 141 Duloxetine NDCs

Other NDCs under ANDA 090694

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

FDA NDC Directory listings under ANDA 090694
ProductStrengthForm · routeLabelerProduct NDC
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8494
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8495
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralNCS HealthCare of KY, LLC dba Vangard Labs0615-8496
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralQPharma, Inc.42708-196
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6281
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6406
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-6775
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7784
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-7897
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralGolden State Medical Supply, Inc.51407-807
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralGolden State Medical Supply, Inc.51407-808
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralGolden State Medical Supply, Inc.51407-809
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralGolden State Medical Supply, Inc.51407-810
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralCoupler LLC67046-1585
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralCoupler LLC67046-1598
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralNuCare Pharmaceuticals, Inc.68071-3775
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralLupin Pharmaceuticals, Inc.68180-294
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralLupin Pharmaceuticals, Inc.68180-295
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralLupin Pharmaceuticals, Inc.68180-296
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralLupin Pharmaceuticals, Inc.68180-297

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