Prescription drug · ANDA
Fluoxetine hydrochloride NDC 16714-114
Fluoxetine hydrochloride 60 mg/1 · Tablet, Film coated · Oral, Oral · NorthStar Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16714-114-01 | 1671401140116714011401 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-114-01)Marketed from Sep 18, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 60 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral, Oral
- Labeler
- NorthStar Rx LLCNDC labeler code 16714
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211721
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 16714-114_e90468ef-aee3-2684-3a9d-7bd58919e9deSPL ID e90468ef-aee3-2684-3a9d-7bd58919e9deSPL set ID 1f8b1834-d5d7-72b6-d2ed-cb074344d59eRxCUI 1190110UNII 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, Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N416714011401followed by a unit qualifier and the quantityPackage 16714-0114-01. 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 tablets are indicated for the treatment of: Major Depressive Disorder (MDD). The efficacy of fluoxetine in MDD was established in one 5 week trial, three 6 week trials, and one maintenance study in adults. The efficacy of fluoxetine was also established in two 8 to 9 week trials in pediatric patients 8 to 18 years of age [see Clinical Studies (14.1) ]. Obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD). The efficacy of fluoxetine in OCD was demonstrated in two 13 week trials in adults and one 13 week trial in pediatric patients 7 to 17 years of age [see Clinical Studies (14.2) ]. Binge-eating and vomiting behaviors in patients with moderate to severe B…
Excerpt only. Read the full label for complete information.
About NDC 16714-114
- What is NDC 16714-114?
- 16714-114 is the product NDC for Fluoxetine hydrochloride, Fluoxetine hydrochloride 60 mg/1 tablet, film coated, listed with the FDA by NorthStar Rx 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?
- NorthStar Rx LLC, NDC labeler code 16714. 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 | For solutionOral | Upsher-Smith Laboratories, LLC | 0832-6032 | 00832-6032-12 |
| Fluoxetine Hydrochloride | Fluoxetine hydrochloride 20 mg/5mL | SolutionOral | ANI Pharmaceuticals, Inc. | 70954-600 | 70954-0600-10 |
| 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 |
Other NDCs under ANDA 211721
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fluoxetine hydrochloride | Fluoxetine hydrochloride 60 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-632 |