Prescription drug · ANDA
Fluoxetine hydrochloride NDC 55111-284
Fluoxetine hydrochloride 90 mg/1 · Capsule, Delayed release pellets · Oral · Dr.Reddy's Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55111-284-48 | 5511102844855111028448 | 1 BLISTER PACK in 1 CARTON (55111-284-48) / 4 CAPSULE, DELAYED RELEASE PELLETS in 1 BLISTER PACKMarketed from Mar 24, 2010 |
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 — 90 mg/1
- Dosage form
- Capsule, Delayed release pellets
- Route
- Oral
- Labeler
- Dr.Reddy's Laboratories LimitedNDC labeler code 55111
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078572
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 55111-284_42f4ab4e-3271-f7cc-8e57-e621d0d3e1d5SPL ID 42f4ab4e-3271-f7cc-8e57-e621d0d3e1d5SPL set ID 887fc670-db67-4cfe-967b-46b38375dae5RxCUI 313995UNII 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
N455111028448followed by a unit qualifier and the quantityPackage 55111-0284-48. 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 delayed-release capsules are indicated for the treatment of: • Acute and maintenance treatment of Major Depressive Disorder [see Clinical Studies ( 14.1 )] . Fluoxetine delayed-release capsules are selective serotonin reuptake inhibitor indicated for: Acute and maintenance treatment of Major Depressive Disorder (MDD) (1)
Excerpt only. Read the full label for complete information.
About NDC 55111-284
- What is NDC 55111-284?
- 55111-284 is the product NDC for Fluoxetine hydrochloride, Fluoxetine hydrochloride 90 mg/1 capsule, delayed release pellets, listed with the FDA by Dr.Reddy's Laboratories Limited. 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?
- Dr.Reddy's Laboratories Limited, NDC labeler code 55111. 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 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 |