What is NDC 33342-389?

33342-389 is the product NDC for Desvenlafaxine Succinate, Desvenlafaxine succinate 100 mg/1 tablet, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 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 Desvenlafaxine Succinate?

10 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Desvenlafaxine Succinate NDC 33342-389

NDC codes

FDA NDC Directory

Product NDC (as listed)33342-389Labeler and product segments. Claims need a package NDC.

Product NDC at billing width33342-0389Add 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
33342-389-07	3334203890733342038907	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-389-07)Marketed from Jun 16, 2018
33342-389-10	3334203891033342038910	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-389-10)Marketed from Jun 16, 2018
33342-389-12	3334203891233342038912	10 BLISTER PACK in 1 CARTON (33342-389-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 16, 2018

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): Desvenlafaxine Succinate
Generic name (nonproprietary): desvenlafaxine succinate
Active ingredients: Desvenlafaxine succinate — 100 mg/1
Dosage form: Tablet, Extended release
Route: Oral
Labeler: Macleods Pharmaceuticals LimitedNDC labeler code 33342
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211427
Marketing start: Jun 16, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 33342-389_edf18b33-a226-44f8-9f42-c409e691ee64SPL ID edf18b33-a226-44f8-9f42-c409e691ee64SPL set ID edf18b33-a226-44f8-9f42-c409e691ee64RxCUI 1874553, 1874559UNII ZB22ENF0XRUPC 0333342389121, 0333342388100, 0333342389107, 0333342388070, 0333342388124, 0333342389077
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

N433342038907 followed by a unit qualifier and the quantity

Package 33342-0389-07. 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 Aug 9, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies ( 14 )]. Desvenlafaxine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 33342-389

What is NDC 33342-389?: 33342-389 is the product NDC for Desvenlafaxine Succinate, Desvenlafaxine succinate 100 mg/1 tablet, extended release, listed with the FDA by Macleods Pharmaceuticals Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Desvenlafaxine Succinate.
What is the active ingredient?: Desvenlafaxine succinate.
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 Desvenlafaxine Succinate?: 10 other product NDCs are listed under this name. See all Desvenlafaxine Succinate 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 Desvenlafaxine Succinate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Desvenlafaxine Succinate	Desvenlafaxine succinate 100 mg/1	Tablet, Film coated, Extended releaseOral	Preferred Pharmaceuticals Inc.	68788-8556	68788-8556-0168788-8556-0368788-8556-06+1 more
Desvenlafaxine Succinate	Desvenlafaxine succinate 25 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-7468	50090-7468-0050090-7468-01
Desvenlafaxine Succinate	Desvenlafaxine succinate 25 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-604	68180-0604-06
Desvenlafaxine Succinate	Desvenlafaxine succinate 25 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-2494	71335-2494-0171335-2494-0271335-2494-03+1 more
Desvenlafaxine Succinate	Desvenlafaxine succinate 50 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-388	33342-0388-0733342-0388-1033342-0388-12
Desvenlafaxine Succinate	Desvenlafaxine succinate 50 mg/1	Tablet, Film coated, Extended releaseOral	A-S Medication Solutions	50090-6894	50090-6894-00
Desvenlafaxine Succinate	Desvenlafaxine succinate 50 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-592	68180-0592-06
Desvenlafaxine Succinate	Desvenlafaxine succinate 100 mg/1	Tablet, Film coated, Extended releaseOral	Lupin Pharmaceuticals, Inc.	68180-593	68180-0593-06
Desvenlafaxine Succinate	Desvenlafaxine succinate 50 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-1150	71335-1150-0171335-1150-0271335-1150-03+2 more
Desvenlafaxine Succinate	Desvenlafaxine succinate 100 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-1331	71335-1331-0171335-1331-0271335-1331-03+1 more

Other NDCs under ANDA 211427

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

FDA NDC Directory listings under ANDA 211427
Product	Strength	Form · route	Labeler	Product NDC
Desvenlafaxine Succinate	Desvenlafaxine succinate 50 mg/1	Tablet, Extended releaseOral	Macleods Pharmaceuticals Limited	33342-388