Prescription drug · ANDA

Duloxetine (Duloxetine hydrochloride) NDC 63187-666

Duloxetine hydrochloride 60 mg/1 · Capsule, Delayed release · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-666Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0666Add 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
63187-666-30631870666306318706663030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-666-30)Marketed from Dec 1, 2018
63187-666-60631870666606318706666060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-666-60)Marketed from Dec 1, 2018
63187-666-90631870666906318706669090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-666-90)Marketed from Dec 1, 2018

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 hydrochloride
Active ingredients
Duloxetine hydrochloride — 60 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 090778
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 63187-666_516a73f5-d543-4c59-9281-cf7b5a6dd2bfSPL ID 516a73f5-d543-4c59-9281-cf7b5a6dd2bfSPL set ID 51c342c9-b9c6-467d-8fea-b73d72e3febcRxCUI 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

N463187066630 followed by a unit qualifier and the quantity

Package 63187-0666-30. 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 [ see Clinical Studies (14.1 )] • Generalized Anxiety Disorder [ see Clinical Studies (14.2)] • Diabetic Peripheral Neuropathy [ see Clinical Studies (14.3)] • Chronic Musculoskeletal Pain [ see Clinical Studies (14.5)] Duloxetine delayed-release capsules USP are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: • Major Depressive Disorder (MDD) ( 1 ) • Generalized Anxiety Disorder (GAD) ( 1 ) • Diabetic Peripheral Neuropathic Pain (DPNP) ( 1 ) • Chronic Musculoskeletal Pain ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-666

What is NDC 63187-666?
63187-666 is the product NDC for Duloxetine (duloxetine hydrochloride), Duloxetine hydrochloride 60 mg/1 capsule, delayed release, 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 (Duloxetine Hydrochloride).
What is the active ingredient?
Duloxetine hydrochloride.
Who is the labeler?
Proficient Rx LP, NDC labeler code 63187. 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 090778

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

FDA NDC Directory listings under ANDA 090778
ProductStrengthForm · routeLabelerProduct NDC
Duloxetineduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralAurobindo Pharma Limited59651-279
Duloxetineduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralProficient Rx LP63187-612
Duloxetineduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-401
Duloxetineduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-402
Duloxetine HCL DRduloxetine hclDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0014

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