Prescription drug · ANDA

Fluoxetine (Fluoxetine hydrochloride) NDC 70518-0417

Fluoxetine hydrochloride 20 mg/1 · Capsule · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-0417Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-0417Add 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
70518-0417-1705180417017051804170130 CAPSULE in 1 BLISTER PACK (70518-0417-1)Marketed from Apr 14, 2017
70518-0417-2705180417027051804170290 CAPSULE in 1 BOTTLE, PLASTIC (70518-0417-2)Marketed from Apr 20, 2017
70518-0417-3705180417037051804170330 CAPSULE in 1 BOTTLE, PLASTIC (70518-0417-3)Marketed from Apr 26, 2017

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)
Fluoxetine
Generic name (nonproprietary)
fluoxetine hydrochloride
Active ingredients
Fluoxetine hydrochloride — 20 mg/1
Dosage form
Capsule
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
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 70518-0417_5519b4bb-ba0c-cd58-e063-6294a90ab317SPL ID 5519b4bb-ba0c-cd58-e063-6294a90ab317SPL set ID 20516384-6517-48be-bd6e-718250878a76RxCUI 310385UNII 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

N470518041701 followed by a unit qualifier and the quantity

Package 70518-0417-01. 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)

Fluoxetine capsules are indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies (14.1) ] . Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) [see Clinical Studies (14.2) ] . Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa [see Clinical Studies (14.3) ] . Acute treatment of Panic Disorder, with or without agoraphobia [see Clinical Studies (14.4) ] . Fluoxetine capsules and Olanzapine in Combination are indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-0417

What is NDC 70518-0417?
70518-0417 is the product NDC for Fluoxetine (fluoxetine hydrochloride), Fluoxetine hydrochloride 20 mg/1 capsule, listed with the FDA by REMEDYREPACK INC.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Fluoxetine (Fluoxetine Hydrochloride).
What is the active ingredient?
Fluoxetine hydrochloride.
Who is the labeler?
REMEDYREPACK INC., NDC labeler code 70518. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluoxetine?
200 other product NDCs are listed under this name. See all Fluoxetine 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 Fluoxetine NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralCoupler LLC67046-040567046-0405-03
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralCoupler LLC67046-169567046-1695-03
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralAmerican Health Packaging68002-10568002-0105-01
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-03187441-0031-01
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralCoupler LLC67046-055267046-0552-03
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralCoupler LLC67046-208367046-2083-03
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralREMEDYREPACK INC.70518-461170518-4611-00
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralCoupler LLC67046-167067046-1670-03
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralNorthwind Health Company, LLC82868-10582868-0105-3082868-0105-90
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralREMEDYREPACK INC.70518-457670518-4576-00

All 201 Fluoxetine NDCs

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/1CapsuleOralMajor Pharmaceuticals0904-7346
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralNorthwind Health Company, LLC82868-105
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralBluePoint Laboratories68001-400
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralAmerican Health Packaging68002-105
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralBluePoint Laboratories68001-399
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralBluePoint Laboratories68001-401
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralUnit Dose Solutions, Inc.87441-031
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralNorthStar Rx LLC72603-490
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralNorthStar Rx LLC72603-488
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralNorthStar Rx LLC72603-489
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-7952
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-0745
FluoxetineFluoxetine hydrochloride 20 mg/1CapsuleOralA-S Medication Solutions50090-7951
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralCardinal Health 107, LLC55154-2638
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-993
FluoxetineFluoxetine hydrochloride 10 mg/1CapsuleOralCoupler LLC67046-1695
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 40 mg/1CapsuleOralAurobindo Pharma Limited65862-194
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralAurobindo Pharma Limited65862-192
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 20 mg/1CapsuleOralAurobindo Pharma Limited65862-193
Fluoxetinefluoxetine hydrochlorideFluoxetine hydrochloride 10 mg/1CapsuleOralA-S Medication Solutions50090-6065

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