Prescription drug · NDA
Prozac (fluoxetine hydrochloride) NDC 0777-3105
Fluoxetine hydrochloride 20 mg/1 · Capsule · Oral · Dista Products Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0777-3105-02 | 00777310502 | 100 CAPSULE in 1 BOTTLE (0777-3105-02)Marketed from Feb 1, 1988 | |
| 0777-3105-30 | 00777310530 | 30 CAPSULE in 1 BOTTLE (0777-3105-30)Marketed from Feb 1, 1988 |
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)
- Prozac
- Generic name (nonproprietary)
- fluoxetine hydrochloride
- Active ingredients
- Fluoxetine hydrochloride — 20 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Dista Products Company
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018936
- Marketing start
- Marketing end
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0777-3105_e49a90e3-e7da-4377-8736-ebe9f53c3097SPL ID e49a90e3-e7da-4377-8736-ebe9f53c3097SPL set ID c88f33ed-6dfb-4c5e-bc01-d8e36dd97299RxCUI 104849, 205535, 261287, 310384, 310385, 313989UNII I9W7N6B1KJUPC 0307773107302, 0307773104028, 0307773105025
- 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
N400777310502followed by a unit qualifier and the quantityPackage 00777-3105-02. 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)
PROZAC ® is 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 )]. PROZAC and Olanzapine in Combination is indicated for the treatment of: Acute treatment of depressive episodes associated with Bipolar I Disorder. Treatment res…
Excerpt only. Read the full label for complete information.