NDC codes

FDA NDC Directory
Product NDC (as listed)67877-263Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67877-0263Add 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
67877-263-016787702630167877026301100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-263-01)Marketed from May 1, 2012
67877-263-1067877026310678770263101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-263-10)Marketed from May 1, 2012
67877-263-30678770263306787702633030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-263-30)Marketed from May 1, 2012
67877-263-60678770263606787702636060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-263-60)Marketed from May 1, 2012
67877-263-90678770263906787702639090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-263-90)Marketed from May 1, 2012

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
Generic name (nonproprietary)
duloxetine
Active ingredients
Duloxetine hydrochloride — 20 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Ascend Laboratories, LLCNDC labeler code 67877
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203197
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 67877-263_958fae45-5e7a-4f8b-80b7-5934222747b5SPL ID 958fae45-5e7a-4f8b-80b7-5934222747b5SPL set ID e6477c41-97a2-45a7-94b5-487aa65199f6RxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0367877263106

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

N467877026301 followed by a unit qualifier and the quantity

Package 67877-0263-01. 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)

Duloxetine is 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 hydrochloride 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 adu…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67877-263

What is NDC 67877-263?
67877-263 is the product NDC for Duloxetine, Duloxetine hydrochloride 20 mg/1 capsule, delayed release, listed with the FDA by Ascend Laboratories, LLC. It has 5 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?
Ascend Laboratories, LLC, NDC labeler code 67877. 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 203197

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

FDA NDC Directory listings under ANDA 203197
ProductStrengthForm · routeLabelerProduct NDC
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralAscend Laboratories, LLC67877-264
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralAscend Laboratories, LLC67877-265
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralProficient Rx LP71205-445
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-1672
Duloxetine HCL DRduloxetine hclDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0012

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