NDC codes

FDA NDC Directory
Product NDC (as listed)0093-7198Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00093-7198Add 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
0093-7198-010009371980100093719801100 CAPSULE in 1 BOTTLE (0093-7198-01)Marketed from Sep 8, 2008
0093-7198-050009371980500093719805500 CAPSULE in 1 BOTTLE (0093-7198-05)Marketed from Sep 23, 2008
0093-7198-56000937198560009371985630 CAPSULE in 1 BOTTLE (0093-7198-56)Marketed from Jan 30, 2002

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Active ingredients
Fluoxetine hydrochloride — 40 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Teva Pharmaceuticals USA, Inc.NDC labeler code 0093
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 075452
Marketing start
Listing expires
Other FDA classes
Serotonin Uptake Inhibitors (Mechanism)
Identifiers
Product ID 0093-7198_61c76dc7-bc11-4dec-bf02-b4ef5474cbb3SPL ID 61c76dc7-bc11-4dec-bf02-b4ef5474cbb3SPL set ID 369dbfba-9de4-433c-8680-2ec047b8f8d9RxCUI 313989UNII I9W7N6B1KJUPC 0300937198567
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

N400093719801 followed by a unit qualifier and the quantity

Package 00093-7198-01. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0093-7198

What is NDC 0093-7198?
0093-7198 is the product NDC for Fluoxetine, Fluoxetine hydrochloride 40 mg/1 capsule, listed with the FDA by Teva Pharmaceuticals USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Fluoxetine.
What is the active ingredient?
Fluoxetine hydrochloride.
Who is the labeler?
Teva Pharmaceuticals USA, Inc., NDC labeler code 0093. 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?
194 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 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
FluoxetineFluoxetine hydrochloride 20 mg/1Tablet, Film coatedOralAurobindo Pharma Limited84386-10584386-0105-0184386-0105-30

All 195 Fluoxetine NDCs

Other NDCs under ANDA 075452

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

FDA NDC Directory listings under ANDA 075452
ProductStrengthForm · routeLabelerProduct NDC
FluoxetineFluoxetine hydrochloride 40 mg/1CapsuleOralProficient Rx LP71205-188

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