NDC codes

FDA NDC Directory
Product NDC (as listed)50771-001Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50771-0001Add 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
50771-001-025077100010250771000102100 TABLET in 1 BOTTLE, PLASTIC (50771-001-02)Marketed from Sep 6, 2016

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 — 25 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Yaopharma Co., Ltd.NDC labeler code 50771
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202036
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 50771-001_5611f94b-f739-27f2-e063-6394a90ad3fdSPL ID 5611f94b-f739-27f2-e063-6394a90ad3fdSPL set ID 38fd2c97-cd30-2f7d-e054-00144ff8d46cRxCUI 313580, 313582, 313584, 313586, 314277UNII 7D7RX5A8MOUPC 0350771003022, 0350771002025, 0350771001028, 0350771004029

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

N450771000102 followed by a unit qualifier and the quantity

Package 50771-0001-02. 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)

INDICATIONS AND USAGE Venlafaxine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of venlafaxine tablets, USP in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III or DSM-III-R category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see CLINICAL TRIALS ). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should incl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50771-001

What is NDC 50771-001?
50771-001 is the product NDC for Venlafaxine Hydrochloride, Venlafaxine hydrochloride 25 mg/1 tablet, listed with the FDA by Yaopharma Co., Ltd.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Venlafaxine Hydrochloride.
What is the active ingredient?
Venlafaxine hydrochloride.
Who is the labeler?
Yaopharma Co., Ltd., NDC labeler code 50771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Venlafaxine Hydrochloride?
203 other product NDCs are listed under this name. See all Venlafaxine Hydrochloride 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 Venlafaxine Hydrochloride NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralCoupler LLC67046-040667046-0406-03
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-12524658-0125-1024658-0125-3024658-0125-90
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-12624658-0126-1024658-0126-3024658-0126-90
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-12724658-0127-0524658-0127-3024658-0127-90
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralCoupler LLC67046-039067046-0390-03
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralCoupler LLC67046-052767046-0527-03
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralNorthStar RxLLC72603-74872603-0748-01
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralNorthStar RxLLC72603-74772603-0747-01
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralNorthStar RxLLC72603-74972603-0749-01
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-463270518-4632-00

All 204 Venlafaxine Hydrochloride NDCs

Other NDCs under ANDA 202036

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

FDA NDC Directory listings under ANDA 202036
ProductStrengthForm · routeLabelerProduct NDC
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1TabletOralYaopharma Co., Ltd.50771-002
Venlafaxine HydrochlorideVenlafaxine hydrochloride 50 mg/1TabletOralYaopharma Co., Ltd.50771-003
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1TabletOralYaopharma Co., Ltd.50771-004
Venlafaxine HydrochlorideVenlafaxine hydrochloride 100 mg/1TabletOralYaopharma Co., Ltd.50771-005

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