Prescription drug · NDA
Ocuflox (Ofloxacin) NDC 11980-779
Ofloxacin 3 mg/mL · Solution/ drops · Ophthalmic · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11980-779-05 | 11980077905 | 1 BOTTLE, DROPPER in 1 CARTON (11980-779-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Aug 1, 1993 |
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)
- Ocuflox
- Generic name (nonproprietary)
- ofloxacin
- Active ingredients
- Ofloxacin — 3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Allergan, Inc.NDC labeler code 11980
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019921
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 11980-779_4ba88457-b1b2-4bbc-b086-a2bab56752a0SPL ID 4ba88457-b1b2-4bbc-b086-a2bab56752a0SPL set ID 7aab4449-3dda-4e2c-8e40-b3244a548bf5RxCUI 207202, 312075UNII A4P49JAZ9H
- Pharmacologic class
- Quinolone Antimicrobial
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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N411980077905followed by a unit qualifier and the quantityPackage 11980-0779-05. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE OCUFLOX ® ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Enterobacter cloacae Staphylococcus epidermidis Haemophilus influenzae Streptococcus pneumoniae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Gram-negative bacteria: Staphylococcus aureus Pseudomonas aeruginosa Staphylococcus epidermidis Serratia marcescens* Streptococcus pneumoniae Anaerobic species: Propionibacterium acnes *Efficacy for this organism was studied in fewer than 10 infections
Excerpt only. Read the full label for complete information.
About NDC 11980-779
- What is NDC 11980-779?
- 11980-779 is the product NDC for Ocuflox (ofloxacin), Ofloxacin 3 mg/mL solution/ drops, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ocuflox (Ofloxacin).
- What is the active ingredient?
- Ofloxacin.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 11980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ocuflox?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.