Prescription drug · ANDA

Fluoxetine (fluoxetine hydrochloride) NDC 68001-401

Fluoxetine hydrochloride 40 mg/1 · Capsule · Oral · BluePoint Laboratories

NDC codes

FDA NDC Directory
Product NDC (as listed)68001-401Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0401Add 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
68001-401-0068001040100100 CAPSULE in 1 BOTTLE (68001-401-00)Marketed from Jun 19, 2019
68001-401-0368001040103500 CAPSULE in 1 BOTTLE (68001-401-03)Marketed from Jun 19, 2019
68001-401-046800104010430 CAPSULE in 1 BOTTLE (68001-401-04)Marketed from Jun 19, 2019

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)
Fluoxetine
Generic name (nonproprietary)
fluoxetine hydrochloride
Active ingredients
Fluoxetine hydrochloride — 40 mg/1
Dosage form
Capsule
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078619
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 68001-401_0c3d632c-6b3e-4e78-e063-6394a90a7ed2SPL ID 0c3d632c-6b3e-4e78-e063-6394a90a7ed2SPL set ID f89a5800-6fdb-4938-a28e-3bf1aeb1c21aRxCUI 310384, 310385, 313989UNII I9W7N6B1KJ
Pharmacologic class
Serotonin Reuptake Inhibitor

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

N468001040100 followed by a unit qualifier and the quantity

Package 68001-0401-00. 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 078619

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

FDA NDC Directory listings under ANDA 078619
ProductStrengthForm · routeLabelerProduct NDC
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralREMEDYREPACK INC.70518-0417
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralNorthwind Health Company, LLC51655-981
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-192
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralNorthStar Rx LLC16714-721
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralAurobindo Pharma Limited65862-192
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralAurobindo Pharma Limited65862-193
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralNorthStar Rx LLC16714-720
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralQPharma Inc42708-182
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralAurobindo Pharma Limited65862-194
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-7914
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralNorthStar Rx LLC16714-722
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralBoswell Pharmacy Services LLC d/b/a BPS Wholesale83209-721
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralA-S Medication Solutions50090-7915
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.72789-554
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralQPharma Inc42708-200
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-100
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-101
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralQUALLENT PHARMACEUTICALS HEALTH LLC82009-102
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-7951
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-7952

Showing 20 of 40.

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in