Desvenlafaxine NDC 0054-0401

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0401Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0401Add 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	Copy
0054-0401-13	00054040113	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-13)Marketed from Mar 1, 2017
0054-0401-22	00054040122	90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0054-0401-22)Marketed from Mar 1, 2017

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary): desvenlafaxine
Active ingredients: Desvenlafaxine succinate — 100 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204083
Marketing start: Mar 1, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 0054-0401_c5148154-683f-4369-bb65-9f6f43a64e2bSPL ID c5148154-683f-4369-bb65-9f6f43a64e2bSPL set ID 662890ff-d254-40e0-a9fe-f07ab94d65d6RxCUI 1607617, 1874553, 1874559UNII ZB22ENF0XRUPC 0300540400132, 0300540603137
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

N400054040113 followed by a unit qualifier and the quantity

Package 00054-0401-13. 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 Dec 3, 2025. 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)

Other NDCs under ANDA 204083

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

FDA NDC Directory listings under ANDA 204083
Product	Strength	Form · route	Labeler	Product NDC
Desvenlafaxine	Desvenlafaxine succinate 50 mg/1	Tablet, Film coated, Extended releaseOral	Hikma Pharmaceuticals USA Inc.	0054-0400
Desvenlafaxine	Desvenlafaxine succinate 25 mg/1	Tablet, Film coated, Extended releaseOral	Hikma Pharmaceuticals USA Inc.	0054-0603