Prescription drug · ANDA

Venlafaxine hydrochloride ER (Venlafaxine hydrochloride) NDC 80425-0297

Venlafaxine hydrochloride 150 mg/1 · Capsule, Extended release · Oral · Advanced Rx Pharmacy of Tennessee, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0297Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0297Add 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
80425-0297-18042502970130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0297-1)Marketed from Apr 10, 2023
80425-0297-28042502970260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0297-2)Marketed from Apr 10, 2023
80425-0297-38042502970390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0297-3)Marketed from Apr 10, 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 — 150 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 200834
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 80425-0297_2a9ba8f4-6ced-e827-e063-6394a90a0300SPL ID 2a9ba8f4-6ced-e827-e063-6394a90a0300SPL set ID f8fd4381-52f2-d9c1-e053-6394a90a08e5RxCUI 313581UNII 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

N480425029701 followed by a unit qualifier and the quantity

Package 80425-0297-01. 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 Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: Major Depressive Disorder (MDD) [see CLINICAL STUDIES (14.1)] Generalized Anxiety Disorder (GAD) [see CLINICAL STUDIES (14.2)] Social Anxiety Disorder (SAD) [see CLINICAL STUDIES (14.3)] Panic Disorder (PD) [see CLINICAL STUDIES (14.4)]

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0297

What is NDC 80425-0297?
80425-0297 is the product NDC for Venlafaxine hydrochloride ER (venlafaxine hydrochloride), Venlafaxine hydrochloride 150 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 75 mg/1Capsule, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-029680425-0296-0180425-0296-0280425-0296-03
Venlafaxine Hydrochloride ERvenlafaxine hydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-029080425-0290-0180425-0290-0280425-0290-03

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 HCL ERVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralDirect_Rx72189-363
Venlafaxine HCL ERVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralDirect_Rx72189-414
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7487
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7488
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralMajor Pharmaceuticals0904-7489
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralQPharma, Inc.42708-194
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-2180
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-2281
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-2519
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-6517
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-6599
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-6896
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7940
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7941
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-7942
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralNorthwind Health Company, LLC51655-849
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralCardinal Health 107, LLC55154-0197
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralST. MARY'S MEDICAL PARK PHARMACY60760-836
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited65862-527
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralAurobindo Pharma Limited65862-528

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