Prescription drug · ANDA

Venlafaxine Hydrochloride ER (Venlafaxine hydrochloride) NDC 80425-0290

Venlafaxine hydrochloride 37.5 mg/1 · Capsule, Extended release · Oral · Advanced Rx Pharmacy of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0290Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0290Add 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
80425-0290-1804250290018042502900130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0290-1)Marketed from Mar 24, 2023
80425-0290-2804250290028042502900260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0290-2)Marketed from Mar 24, 2023
80425-0290-3804250290038042502900390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0290-3)Marketed from Mar 24, 2023

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)
Venlafaxine Hydrochloride ERSuffix: ER
Generic name (nonproprietary)
venlafaxine hydrochloride
Active ingredients
Venlafaxine hydrochloride — 37.5 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Labeler
Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214654
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 80425-0290_2a9bad62-b303-697c-e063-6294a90aa395SPL ID 2a9bad62-b303-697c-e063-6294a90aa395SPL set ID f7a9741b-2dd3-d8f3-e053-6294a90a4d73RxCUI 313583UNII 7D7RX5A8MO

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

N480425029001 followed by a unit qualifier and the quantity

Package 80425-0290-01. 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)

1. Indications and Usage 1.1 Major Depressive Disorder Venlafaxine Hydrochloride Extended-Release Capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. 1.2 Generalized Anxiety Disorder Venlafaxine Hydrochloride Extended-Release Capsules are indicated for the treatment of Generalized Anxiety Disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials. 1.3 Social Anxiety Disorder Venlafaxine Hydrochloride Extended-Release Capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficac…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0290

What is NDC 80425-0290?
80425-0290 is the product NDC for Venlafaxine Hydrochloride ER (venlafaxine hydrochloride), Venlafaxine hydrochloride 37.5 mg/1 capsule, extended release, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Venlafaxine Hydrochloride ER (Venlafaxine Hydrochloride).
What is the active ingredient?
Venlafaxine hydrochloride.
Who is the labeler?
Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 ER?
2 other product NDCs are listed under this name. See all Venlafaxine Hydrochloride ER 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 ER NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Venlafaxine hydrochloride ERvenlafaxine hydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-029780425-0297-0180425-0297-0280425-0297-03
Venlafaxine hydrochloride ERvenlafaxine hydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-029680425-0296-0180425-0296-0280425-0296-03

Other NDCs under ANDA 214654

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

FDA NDC Directory listings under ANDA 214654
ProductStrengthForm · routeLabelerProduct NDC
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-125
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-126
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS24658-127
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralEpic Pharma, LLC42806-601
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralEpic Pharma, LLC42806-602
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralEpic Pharma, LLC42806-603
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-6834
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7317
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7319
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7323
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7324
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-3638
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralNuCare Pharmaceuticals, Inc.68071-3653
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8682
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralPreferred Pharmaceuticals Inc.68788-8694
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-3971
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-4151
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-4154
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2421
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-2495

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