What is NDC 33342-161?

33342-161 is the product NDC for Duloxetine Hydrochloride, Duloxetine hydrochloride 30 mg/1 capsule, delayed release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.

Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 Hydrochloride?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Duloxetine Hydrochloride NDC 33342-161

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-161Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0161Add 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
33342-161-07	3334201610733342016107	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-07)Marketed from Mar 24, 2017
33342-161-10	3334201611033342016110	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-10)Marketed from Mar 24, 2017
33342-161-12	3334201611233342016112	10 BLISTER PACK in 1 CARTON (33342-161-12) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACKMarketed from Mar 24, 2017
33342-161-44	3334201614433342016144	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-161-44)Marketed from Mar 24, 2017

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 Hydrochloride
Generic name (nonproprietary): duloxetine hydrochloride
Active ingredients: Duloxetine hydrochloride — 30 mg/1
Dosage form: Capsule, Delayed release
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204815
Marketing start: Mar 24, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 33342-161_d2bdee38-c510-432f-bf05-a8a573cf459cSPL ID d2bdee38-c510-432f-bf05-a8a573cf459cSPL set ID 177ce798-3924-416b-ba37-23dfa911a43bRxCUI 596926, 596930, 596934UNII 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

N433342016107 followed by a unit qualifier and the quantity

Package 33342-0161-07. 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 29, 2025. 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 • 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 neuropathic pain (DPNP) in adults ( 1 ) • Fibromyalgia (FM)…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-161

What is NDC 33342-161?: 33342-161 is the product NDC for Duloxetine Hydrochloride, Duloxetine hydrochloride 30 mg/1 capsule, delayed release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Duloxetine Hydrochloride.
What is the active ingredient?: Duloxetine hydrochloride.
Who is the labeler?: Macleods Pharmaceuticals Limited, NDC labeler code 33342. 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 Hydrochloride?: 11 other product NDCs are listed under this name. See all Duloxetine Hydrochloride 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 Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Duloxetine Hydrochlorideduloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-278	62332-0278-3062332-0278-6062332-0278-90+1 more
Duloxetine Hydrochlorideduloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-279	62332-0279-3062332-0279-9062332-0279-91
Duloxetine Hydrochlorideduloxetine	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Inc.	62332-280	62332-0280-3062332-0280-9062332-0280-91
Duloxetine Hydrochloride	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed release pelletsOral	Yaopharma Co., Ltd.	50771-201	50771-0201-01
Duloxetine Hydrochloride	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed release pelletsOral	Yaopharma Co., Ltd.	50771-202	50771-0202-0150771-0202-02
Duloxetine Hydrochloride	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed release pelletsOral	Yaopharma Co., Ltd.	50771-203	50771-0203-0150771-0203-02
Duloxetine Hydrochloride	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-160	33342-0160-0933342-0160-1033342-0160-12+1 more
Duloxetine Hydrochloride	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-162	33342-0162-0733342-0162-1033342-0162-12+1 more
Duloxetine Hydrochlorideduloxetine	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Limited	46708-278	46708-0278-3046708-0278-6046708-0278-90+1 more
Duloxetine Hydrochlorideduloxetine	Duloxetine hydrochloride 30 mg/1	Capsule, Delayed releaseOral	Alembic Pharmaceuticals Limited	46708-279	46708-0279-3046708-0279-9046708-0279-91

All 12 Duloxetine Hydrochloride NDCs

Other NDCs under ANDA 204815

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

FDA NDC Directory listings under ANDA 204815
Product	Strength	Form · route	Labeler	Product NDC
Duloxetine Hydrochloride	Duloxetine hydrochloride 20 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-160
Duloxetine Hydrochloride	Duloxetine hydrochloride 60 mg/1	Capsule, Delayed releaseOral	Macleods Pharmaceuticals Limited	33342-162