Fluoxetine NDC 68788-8618

NDC codes

FDA NDC Directory

Product NDC (as listed)68788-8618Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68788-8618Add 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 NDC	11-digit (billing)	Package
68788-8618-1	68788861801	100 CAPSULE in 1 BOTTLE (68788-8618-1)Marketed from Mar 28, 2024
68788-8618-3	68788861803	30 CAPSULE in 1 BOTTLE (68788-8618-3)Marketed from Mar 28, 2024
68788-8618-6	68788861806	90 CAPSULE in 1 BOTTLE (68788-8618-6)Marketed from Mar 28, 2024

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
Active ingredients: Fluoxetine hydrochloride — 40 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Preferred Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201336
Marketing start: Mar 28, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 68788-8618_ec67d3fd-5f16-4fc1-b174-90ede65171a0SPL ID ec67d3fd-5f16-4fc1-b174-90ede65171a0SPL set ID 54ded68c-1d2e-453d-b155-84c3102e1f0eRxCUI 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

N468788861801 followed by a unit qualifier and the quantity

Package 68788-8618-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 201336

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

FDA NDC Directory listings under ANDA 201336
Product	Strength	Form · route	Labeler	Product NDC
Fluoxetine	Fluoxetine hydrochloride 20 mg/1	CapsuleOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-029
Fluoxetine	Fluoxetine hydrochloride 10 mg/1	CapsuleOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-028
Fluoxetine	Fluoxetine hydrochloride 40 mg/1	CapsuleOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-030