Prescription drug · ANDA
Fluoxetine hydrochloride NDC 0832-6032
Fluoxetine hydrochloride 20 mg/5mL · For solution · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-6032-12 | 0083260321200832603212 | 1 BOTTLE in 1 CARTON (0832-6032-12) / 120 mL in 1 BOTTLEMarketed from Nov 30, 2022 |
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 hydrochloride
- Generic name (nonproprietary)
- fluoxetine hydrochloride
- Active ingredients
- Fluoxetine hydrochloride — 20 mg/5mL
- Dosage form
- For solution
- Route
- Oral
- Labeler
- Upsher-Smith Laboratories, LLCNDC labeler code 0832
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216953
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 0832-6032_178bf3b7-fdee-454e-9446-822a1077d985SPL ID 178bf3b7-fdee-454e-9446-822a1077d985SPL set ID be2e4325-feb9-4957-99c0-0a741a2d71a0RxCUI 310386UNII 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
N400832603212followed by a unit qualifier and the quantityPackage 00832-6032-12. 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 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) ] . Fluoxetine monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder or the treatment of treatment resistant depr…
Excerpt only. Read the full label for complete information.
About NDC 0832-6032
- What is NDC 0832-6032?
- 0832-6032 is the product NDC for Fluoxetine hydrochloride, Fluoxetine hydrochloride 20 mg/5mL for solution, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluoxetine hydrochloride.
- What is the active ingredient?
- Fluoxetine hydrochloride.
- Who is the labeler?
- Upsher-Smith Laboratories, LLC, NDC labeler code 0832. 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 hydrochloride?
- 19 other product NDCs are listed under this name. See all Fluoxetine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluoxetine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluoxetine Hydrochloride | Fluoxetine hydrochloride 20 mg/5mL | SolutionOral | ANI Pharmaceuticals, Inc. | 70954-600 | 70954-0600-10 |
| Fluoxetine hydrochloride | Fluoxetine hydrochloride 60 mg/1 | Tablet, Film coatedOral, Oral | NorthStar Rx LLC | 16714-114 | 16714-0114-01 |
| Fluoxetine Hydrochloride | Fluoxetine hydrochloride 10 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-998 | 68180-0998-0168180-0998-06 |
| Fluoxetine Hydrochloride | Fluoxetine hydrochloride 20 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-999 | 68180-0999-0168180-0999-06 |
| Fluoxetine Hydrochloride | Fluoxetine hydrochloride 60 mg/1 | TabletOral | Lupin Pharmaceuticals, Inc. | 68180-997 | 68180-0997-06 |
| Fluoxetine Hydrochloride | Fluoxetine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 51672-5306 | 51672-5306-0251672-5306-06 |
| Fluoxetine hydrochloride | Fluoxetine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-632 | 43598-0632-0143598-0632-30 |
| Fluoxetine Hydrochloride | Fluoxetine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-242 | 46708-0242-3046708-0242-3146708-0242-91 |
| Fluoxetine Hydrochloride | Fluoxetine hydrochloride 20 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-243 | 46708-0243-3046708-0243-3146708-0243-91 |
| fluoxetine hydrochloride | Fluoxetine hydrochloride 10 mg/1 | Tablet, CoatedOral | Par Health USA, LLC | 49884-335 | 49884-0335-0149884-0335-11 |