Prescription drug · ANDA

Desvenlafaxine (Desvenlafaxine succinate) NDC 68788-7194

Desvenlafaxine succinate 50 mg/1 · Tablet, Extended release · Oral · Preferred Pharmaceutical, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7194Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7194Add 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
68788-7194-16878871940168788719401100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-1)Marketed from Jul 18, 2018
68788-7194-3687887194036878871940330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-3)Marketed from Jul 18, 2018
68788-7194-6687887194066878871940660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-6)Marketed from Jul 18, 2018
68788-7194-9687887194096878871940990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-7194-9)Marketed from Jul 18, 2018

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
Labeler
Preferred Pharmaceutical, Inc.NDC labeler code 68788
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 68788-7194_a6d606dc-0f00-487f-8772-cd2d5f2efe7eSPL ID a6d606dc-0f00-487f-8772-cd2d5f2efe7eSPL set ID 4b786ea1-309d-440c-b091-38d6b1f7fbd3RxCUI 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

N468788719401 followed by a unit qualifier and the quantity

Package 68788-7194-01. 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)

About NDC 68788-7194

What is NDC 68788-7194?
68788-7194 is the product NDC for Desvenlafaxine (desvenlafaxine succinate), Desvenlafaxine succinate 50 mg/1 tablet, extended release, listed with the FDA by Preferred Pharmaceutical, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Desvenlafaxine (Desvenlafaxine Succinate).
What is the active ingredient?
Desvenlafaxine succinate.
Who is the labeler?
Preferred Pharmaceutical, Inc., NDC labeler code 68788. 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?
52 other product NDCs are listed under this name. See all Desvenlafaxine 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 NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
DesvenlafaxineDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralMarlex Pharmaceuticals, Inc.10135-82110135-0821-1010135-0821-1410135-0821-30+1 more
DesvenlafaxineDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralMarlex Pharmaceuticals, Inc.10135-82210135-0822-1010135-0822-1410135-0822-30+1 more
DesvenlafaxineDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals, Inc.68071-533268071-5332-03
DesvenlafaxineDesvenlafaxine succinate 25 mg/1Tablet, Extended releaseOralNorthStar Rx LLC72603-55572603-0555-01
DesvenlafaxineDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralNorthStar Rx LLC72603-55672603-0556-0172603-0556-02
DesvenlafaxineDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralNorthStar Rx LLC72603-55772603-0557-01
DesvenlafaxineDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-876068788-8760-0168788-8760-0368788-8760-06+1 more
DesvenlafaxineDesvenlafaxine succinate 25 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-719050090-7190-0050090-7190-01
DesvenlafaxineDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-773750090-7737-0050090-7737-01
DesvenlafaxineDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-379068071-3790-03

All 53 Desvenlafaxine NDCs

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 releaseOralA-S Medication Solutions50090-5274
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralA-S Medication Solutions50090-5293
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 50 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-7525
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralBryant Ranch Prepack63629-7559
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralCoupler LLC67046-1545
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralPreferred Pharmaceuticals Inc.68788-7175
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 100 mg/1Tablet, Extended releaseOralProficient Rx LP71205-586
Desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 25 mg/1Tablet, Extended releaseOralBryant Ranch Prepack71335-2130
desvenlafaxinedesvenlafaxine succinateDesvenlafaxine succinate 50 mg/1Tablet, Extended releaseOralDIRECT RX72189-147

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