NDC codes

FDA NDC Directory
Product NDC (as listed)63187-702Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0702Add 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
63187-702-306318707023030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-702-30)Marketed from May 2, 2016
63187-702-606318707026060 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-702-60)Marketed from May 2, 2016
63187-702-906318707029090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (63187-702-90)Marketed from May 2, 2016

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 Delayed-ReleaseSuffix: DELAYED-RELEASE
Generic name (nonproprietary)
duloxetine hydrochloride
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 203088
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 63187-702_baacd94b-8cee-45ad-9bb4-cd12a8cfbd58SPL ID baacd94b-8cee-45ad-9bb4-cd12a8cfbd58SPL set ID 41c86c02-68c0-4db5-af1a-941b0d2ffe11RxCUI 596930UNII 9044SC542WUPC 0363187702304

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

N463187070230 followed by a unit qualifier and the quantity

Package 63187-0702-30. 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)

1. INDICATIONS AND USAGE Duloxetine Delayed-release Capsules is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: • Major Depressive Disorder (MDD) ( 1.1 ) • Generalized Anxiety Disorder (GAD) ( 1.2 ) • Diabetic Peripheral Neuropathic Pain (DPNP) ( 1.3 ) • Chronic Musculoskeletal Pain ( 1.5 ) 1.1 Major Depressive Disorder Duloxetine Delayed-release Capsules are indicated for the treatment of major depressive disorder (MDD). The efficacy of Duloxetine Delayed-release Capsules was established in four short-term and one maintenance trial in adults [see Clinical Studies (14.1) ] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly ever…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203088

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

FDA NDC Directory listings under ANDA 203088
ProductStrengthForm · routeLabelerProduct NDC
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack71335-0392
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralBreckenridge Pharmaceutical, Inc.51991-747
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralBreckenridge Pharmaceutical, Inc.51991-746
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralBreckenridge Pharmaceutical, Inc.51991-748
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBreckenridge Pharmaceutical, Inc.51991-750
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralProficient Rx LP63187-720
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralProficient Rx LP63187-735
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack71335-0509
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack63629-9187
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralAphena Pharma Solutions - Tennessee, LLC71610-218
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralGolden State Medical Supply, Inc.51407-819
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralGolden State Medical Supply, Inc.51407-817
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralGolden State Medical Supply, Inc.51407-818
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralA-S Medication Solutions50090-6889
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 20 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1597
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 30 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1598
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralProficient Rx LP82804-024
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 60 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1599
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralBryant Ranch Prepack72162-1600
Duloxetine Delayed-Releaseduloxetine hydrochlorideDuloxetine hydrochloride 40 mg/1Capsule, Delayed release pelletsOralPreferred Pharmaceuticals Inc.68788-8362

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