NDC Package 0904-5785-61 Fluoxetine

Capsule Oral - View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0904-5785-61
Package Description:
100 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK
Product Code:
Proprietary Name:
Fluoxetine
Non-Proprietary Name:
Fluoxetine
Substance Name:
Fluoxetine Hydrochloride
Usage Information:
When using fluoxetine and olanzapine in combination, also refer to the Contraindications section of the package insert for Symbyax.
11-Digit NDC Billing Format:
00904578561
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Major Pharmaceuticals
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Sample Package:
No
FDA Application Number:
ANDA076001
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
02-16-2007
End Marketing Date:
08-31-2025
Exclude Flag:
N
Code Structure:

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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Frequently Asked Questions

What is NDC 0904-5785-61?

The NDC Packaged Code 0904-5785-61 is assigned to a package of 100 blister pack in 1 carton / 1 capsule in 1 blister pack of Fluoxetine, a human prescription drug labeled by Major Pharmaceuticals. The product's dosage form is capsule and is administered via oral form.

Is NDC 0904-5785 included in the NDC Directory?

Yes, Fluoxetine with product code 0904-5785 is active and included in the NDC Directory. The product was first marketed by Major Pharmaceuticals on February 16, 2007.

What is the NDC billing unit for package 0904-5785-61?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

What is the 11-digit format for NDC 0904-5785-61?

The 11-digit format is 00904578561. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20904-5785-615-4-200904-5785-61