What is NDC 71205-445?

71205-445 is the product NDC for Duloxetine, Duloxetine hydrochloride 30 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.

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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Duloxetine NDC 71205-445 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-445Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0445Add 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 NDC	11-digit (billing)	Package
71205-445-30	7120504453071205044530	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-445-30)Marketed from May 19, 2020
71205-445-60	7120504456071205044560	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-445-60)Marketed from May 19, 2020
71205-445-90	7120504459071205044590	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-445-90)Marketed from May 19, 2020

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 — 30 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 203197
Marketing start: May 1, 2012
Listing expires: Dec 31, 2027
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 71205-445_d0a48dfd-af34-470b-9e1f-7678203e9ae5SPL ID d0a48dfd-af34-470b-9e1f-7678203e9ae5SPL set ID d0a48dfd-af34-470b-9e1f-7678203e9ae5RxCUI 596930UNII 9044SC542W
Pharmacologic class: Serotonin and Norepinephrine Reuptake Inhibitor

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

N471205044530 followed by a unit qualifier and the quantity

Package 71205-0445-30. 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 May 1, 2020. This label includes a boxed warning.

Indications (excerpt from the label)

Duloxetine is 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 Hydrochloride is 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 71205-445

What is NDC 71205-445?: 71205-445 is the product NDC for Duloxetine, Duloxetine hydrochloride 30 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	ANI Pharmaceuticals, Inc.	70954-860	70954-0860-30
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	ANI Pharmaceuticals, Inc.	70954-861	70954-0861-20
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	ANI Pharmaceuticals, Inc.	70954-864	70954-0864-20
Duloxetine	Duloxetine hydrochloride 120 mg/1	Capsule, Delayed releaseOral	Almatica Pharma LLC	52427-791	52427-0791-30
Duloxetine	Duloxetine hydrochloride 80 mg/1	Capsule, Delayed releaseOral	Almatica Pharma LLC	52427-821	52427-0821-30
Duloxetine	Duloxetine hydrochloride 90 mg/1	Capsule, Delayed releaseOral	Almatica Pharma LLC	52427-913	52427-0913-30
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Preferred Pharmaceuticals Inc.	68788-4128	68788-4128-0368788-4128-0668788-4128-09
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	Coupler LLC	67046-1598	67046-1598-03
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	Coupler LLC	67046-1585	67046-1585-03
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed release pelletsOral	Preferred Phamaceuticals Inc.	68788-4025	68788-4025-0368788-4025-0668788-4025-09

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
Product	Strength	Form · route	Labeler	Product NDC
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Ascend Laboratories, LLC	67877-263
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	Ascend Laboratories, LLC	67877-264
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	Ascend Laboratories, LLC	67877-265
Duloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	Bryant Ranch Prepack	71335-1672
Duloxetine HCL DRduloxetine hcl	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	Advanced Rx of Tennessee, LLC	80425-0012