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
71205-358-307120503583030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-30)Marketed from Nov 14, 2019
71205-358-607120503586060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-60)Marketed from Nov 14, 2019
71205-358-907120503589090 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
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)

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 60 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-623
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralProficient Rx LP71205-602
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralProficient Rx LP71205-005
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-633
Duloxetine D/RDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralDirect_Rx72189-661
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-634
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralAsclemed USA, Inc.76420-636
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralA-S Medication Solutions50090-5940
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralAjanta Pharma USA Inc.27241-164
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralPD-Rx Pharmaceuticals, Inc.72789-338
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralSt. Mary's Medical Park Pharmacy60760-759
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-1011
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-1054
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-570
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-1139
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralREMEDYREPACK INC.70518-3287
DuloxetineDuloxetine hydrochloride 60 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-596
DuloxetineDuloxetine hydrochloride 20 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-594
DuloxetineDuloxetine hydrochloride 30 mg/1Capsule, Delayed releaseOralBluePoint Laboratories68001-595
DuloxetineDuloxetine hydrochloride 40 mg/1Capsule, Delayed releaseOralQuallent Pharmaceuticals Health LLC82009-172

Showing 20 of 39.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in