Prescription drug · ANDA

Desvenlafaxine (desvenlafaxine succinate) NDC 63629-7525

Desvenlafaxine succinate 50 mg/1 · Tablet, Extended release · Oral · Bryant Ranch Prepack

NDC codes

FDA NDC Directory
Product NDC (as listed)63629-7525Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63629-7525Add 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
63629-7525-16362975250130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7525-1)Marketed from Feb 5, 2018
63629-7525-26362975250228 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7525-2)Marketed from Apr 27, 2018
63629-7525-36362975250360 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7525-3)Marketed from Aug 2, 2018
63629-7525-46362975250490 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7525-4)Marketed from Feb 10, 2022
63629-7525-563629752505180 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7525-5)Marketed from Aug 31, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 succinate
Active ingredients
Desvenlafaxine succinate — 50 mg/1
Dosage form
Tablet, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204003
Marketing start
Listing expires
Other FDA classes
Cytochrome P450 2D6 Inhibitors (Mechanism)Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 63629-7525_1070846d-21cb-48e3-8fe9-d93014c7840cSPL ID 1070846d-21cb-48e3-8fe9-d93014c7840cSPL set ID f99c78ef-5a0a-45af-9b4b-5a78b75fe994RxCUI 1874559UNII ZB22ENF0XR

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

N463629752501 followed by a unit qualifier and the quantity

Package 63629-7525-01. 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 . 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 204003

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

FDA NDC Directory listings under ANDA 204003
ProductStrengthForm · routeLabelerProduct NDC
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralAlembic Pharmaceuticals Limited46708-540
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralAlembic Pharmaceuticals Limited46708-541
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 25 mg/1Tablet, Extended releaseOralAlembic Pharmaceuticals Limited46708-542
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 25 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2130
desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralDIRECT RX72189-147
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralCoupler LLC67046-1545
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralPreferred Pharmaceutical, Inc.68788-7194
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-7175
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-7559
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 25 mg/1Tablet, Extended releaseOralBreckenridge Pharmaceutical, Inc51991-006
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralBreckenridge Pharmaceutical, Inc51991-311
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralBreckenridge Pharmaceutical, Inc51991-312
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 25 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5274
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralProficient Rx LP71205-586
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5293

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