NDC codes

FDA NDC Directory
Product NDC (as listed)71335-1672Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-1672Add 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
71335-1672-1713351672017133516720130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-1)Marketed from Jul 27, 2020
71335-1672-2713351672027133516720260 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-2)Marketed from Aug 28, 2020
71335-1672-3713351672037133516720328 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-3)Marketed from Apr 4, 2024
71335-1672-471335167204713351672046 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-4)Marketed from Apr 4, 2024
71335-1672-5713351672057133516720590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-5)Marketed from Dec 22, 2020
71335-1672-6713351672067133516720615 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-6)Marketed from Jan 7, 2021
71335-1672-77133516720771335167207180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-7)Marketed from Feb 1, 2021
71335-1672-87133516720871335167208120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1672-8)Marketed from Apr 4, 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 — 30 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Bryant Ranch PrepackNDC labeler code 71335
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 71335-1672_a5fa1183-35f7-41b9-8452-5d00ccd868a3SPL ID a5fa1183-35f7-41b9-8452-5d00ccd868a3SPL set ID c52fc4ad-7bda-4824-8edf-117d3d8d6b3dRxCUI 596930UNII 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

N471335167201 followed by a unit qualifier and the quantity

Package 71335-1672-01. 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 71335-1672

What is NDC 71335-1672?
71335-1672 is the product NDC for Duloxetine, Duloxetine hydrochloride 30 mg/1 capsule, delayed release, listed with the FDA by Bryant Ranch Prepack. It has 8 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 20 mg/1Capsule, Delayed releaseOralAscend Laboratories, LLC67877-263
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
Duloxetine HCL DRduloxetine hclDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralAdvanced Rx of Tennessee, LLC80425-0012

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