Prescription drug · ANDA

Venlafaxine Hydrochloride NDC 68788-7891

Venlafaxine hydrochloride 37.5 mg/1 · Capsule, Extended release · Oral · Preferred Pharmaceuticals Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7891Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7891Add 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
68788-7891-36878878910330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7891-3)Marketed from Apr 23, 2021
68788-7891-66878878910660 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7891-6)Marketed from Apr 23, 2021
68788-7891-96878878910990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-7891-9)Marketed from Apr 23, 2021

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
Generic name (nonproprietary)
venlafaxine hydrochloride
Active ingredients
Venlafaxine hydrochloride — 37.5 mg/1
Dosage form
Capsule, Extended release
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212277
Marketing start
Listing expires
Other FDA classes
Norepinephrine Uptake Inhibitors (Mechanism)Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68788-7891_29415840-6854-4c68-8aa3-9850e09fc700SPL ID 29415840-6854-4c68-8aa3-9850e09fc700SPL set ID 6c1d0d4f-c8e2-4035-8f4e-7a46bfe3f059RxCUI 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

N468788789103 followed by a unit qualifier and the quantity

Package 68788-7891-03. 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)

Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: • Major Depressive Disorder (MDD) [see Clinical Studies ( )] • Generalized Anxiety Disorder (GAD) [see Clinical Studies ( )] • Social Anxiety Disorder (SAD) [see Clinical Studies ( )] • Panic Disorder (PD) [see Clinical Studies ( )] Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: • Major Depressive Disorder (MDD) ( ) • Generalized Anxiety Disorder (GAD) ( ) • Social Anxiety Disorder (SAD) ( ) • Panic Disorder (PD) ( )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212277

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

FDA NDC Directory listings under ANDA 212277
ProductStrengthForm · routeLabelerProduct NDC
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralAdvanced Rx of Tennessee, LLC80425-0471
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralAnnora Pharma Private Limited71785-1006
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralAnnora Pharma Private Limited71785-1007
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralAnnora Pharma Private Limited71785-1008
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-5890
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-8068
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralPreferred Pharmaceuticals, Inc.68788-8072
Venlafaxine HCL ERvenlafaxine hclVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0194
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-1812
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralA-S Medication Solutions50090-5942
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralREMEDYREPACK INC.70518-4280
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-1868
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralBryant Ranch Prepack71335-9605
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralNuCare Pharmaceuticals,Inc.68071-2393
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralCamber Pharmaceuticals, Inc.31722-004
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralAvPAK50268-874
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralCamber Pharmaceuticals, Inc.31722-002
Venlafaxine HydrochlorideVenlafaxine hydrochloride 75 mg/1Capsule, Extended releaseOralCamber Pharmaceuticals, Inc.31722-003
Venlafaxine HydrochlorideVenlafaxine hydrochloride 37.5 mg/1Capsule, Extended releaseOralAvPAK50268-873
Venlafaxine HydrochlorideVenlafaxine hydrochloride 150 mg/1Capsule, Extended releaseOralAvPAK50268-875

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