Prescription drug · ANDA

Venlafaxine Hydrochloride NDC 65862-528

Venlafaxine hydrochloride 75 mg/1 · Capsule, Extended release · Oral · Aurobindo Pharma Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)65862-528Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0528Add 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
65862-528-0165862052801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-01)Marketed from Jun 1, 2011
65862-528-106586205281010 BLISTER PACK in 1 CARTON (65862-528-10) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Jun 1, 2011
65862-528-306586205283030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-30)Marketed from Jun 1, 2011
65862-528-35658620528353500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-35)Marketed from Jun 1, 2011
65862-528-476586205284715 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-47)Marketed from Jun 1, 2011
65862-528-906586205289090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-90)Marketed from Jun 1, 2011
65862-528-99658620528991000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-528-99)Marketed from Jun 1, 2011

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)
Venlafaxine Hydrochloride
Generic name (nonproprietary)
venlafaxine hydrochloride
Active ingredients
Venlafaxine hydrochloride — 75 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 200834
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 65862-528_d3f9b554-05be-484f-b9e7-5c8e6b2de9c9SPL ID d3f9b554-05be-484f-b9e7-5c8e6b2de9c9SPL set ID 85d3ce8b-8966-45d9-bdaf-f6f0475096e1RxCUI 313581, 313583, 313585UNII 7D7RX5A8MOUPC 0365862528476, 0365862527479

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

N465862052801 followed by a unit qualifier and the quantity

Package 65862-0528-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 200834

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

FDA NDC Directory listings under ANDA 200834
ProductStrengthForm · routeLabelerProduct NDC
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralNuCare Pharmaceuticals, Inc.68071-3886
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7940
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7489
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-058
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-056
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-057
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralAsclemed USA, Inc.76420-632
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralAsclemed USA, Inc.76420-630
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralAsclemed USA, Inc.76420-631
Venlafaxine HCL ERVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralDirect_Rx72189-414
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited65862-697
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralQPharma, Inc.42708-194
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-2107
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8140
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-5160
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralProficient Rx LP71205-369
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-2259
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-1864
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralCoupler LLC67046-0527
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralProficient Rx LP71205-408

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