What is NDC 31722-169?

31722-169 is the product NDC for Duloxetine, Duloxetine hydrochloride 30 mg/1 capsule, delayed release, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 6 package NDCs, shown above in 10- and 11-digit form.

Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 31722-169 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)31722-169Labeler and product segments. Claims need a package NDC.

Product NDC at billing width31722-0169Add 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
31722-169-01	3172201690131722016901	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-169-01)Marketed from Dec 30, 2020
31722-169-10	3172201691031722016910	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-169-10)Marketed from Dec 30, 2020
31722-169-30	3172201693031722016930	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-169-30)Marketed from Dec 30, 2020
31722-169-31	3172201693131722016931	7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (31722-169-31)Marketed from Dec 30, 2020
31722-169-32	3172201693231722016932	105 CAPSULE, DELAYED RELEASE in 1 CARTON (31722-169-32)Marketed from Dec 30, 2020
31722-169-90	3172201699031722016990	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-169-90)Marketed from Jun 29, 2024

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: Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204343
Marketing start: Dec 30, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 31722-169_232a4dda-8bb0-52fa-e063-6394a90ab09eSPL ID 232a4dda-8bb0-52fa-e063-6394a90ab09eSPL set ID b14feecc-04c6-4b2d-ba55-2e1dbef6b0d7RxCUI 596926, 596930, 596934UNII 9044SC542WUPC 0331722169301, 0331722168601, 0331722170307
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

N431722016901 followed by a unit qualifier and the quantity

Package 31722-0169-01. 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 Sep 28, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Duloxetine delayed-release capsules are 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 delayed-release capsules are 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 neuropathi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 31722-169

What is NDC 31722-169?: 31722-169 is the product NDC for Duloxetine, Duloxetine hydrochloride 30 mg/1 capsule, delayed release, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 6 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?: Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 204343

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

FDA NDC Directory listings under ANDA 204343
Product	Strength	Form · route	Labeler	Product NDC
Duloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Camber Pharmaceuticals, Inc.	31722-168
Duloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	Camber Pharmaceuticals, Inc.	31722-170