Prescription drug · ANDA

Duloxetine NDC 71205-358

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

NDC codes

FDA NDC Directory
Product NDC (as listed)71205-358Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0358Add 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
71205-358-30712050358307120503583030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-30)Marketed from Nov 14, 2019
71205-358-60712050358607120503586060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-60)Marketed from Nov 14, 2019
71205-358-90712050358907120503589090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-90)Marketed from Nov 14, 2019

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 — 60 mg/1
Dosage form
Capsule, Delayed release
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 71205
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208706
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 71205-358_5761ba46-a046-4deb-93b9-87919fbc17d0SPL ID 5761ba46-a046-4deb-93b9-87919fbc17d0SPL set ID e36a6919-568a-4d4a-9920-7a7fe4f3441cRxCUI 596934UNII 9044SC542WUPC 0371205358303

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

N471205035830 followed by a unit qualifier and the quantity

Package 71205-0358-30. 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 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 71205-358

What is NDC 71205-358?
71205-358 is the product NDC for Duloxetine, 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.
What is the active ingredient?
Duloxetine hydrochloride.
Who is the labeler?
Proficient Rx LP, NDC labeler code 71205. 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 208706

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

FDA NDC Directory listings under ANDA 208706
ProductStrengthForm · routeLabelerProduct NDC
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralHAWAII REPACK, INC.85534-0052
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralPreferred Pharmaceuticals Inc.68788-7935
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralHAWAII REPACK, INC.85534-0053
Duloxetine HCL DRduloxetine hclDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0146
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralCoupler LLC67046-1451
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-623
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-954
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralAphena Pharma Solutions - Tennessee, LLC71610-403
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-2017
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralBryant Ranch Prepack71335-3062
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralASCLEMED USA INC.87063-703
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralASCLEMED USA INC.87063-702
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-759
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralASCLEMED USA INC.87063-704
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralProficient Rx LP71205-602
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralProficient Rx LP71205-005
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-1011
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-1054
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-1139
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-3287

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