Prescription drug · ANDA
Flurbiprofen Sodium NDC 50090-3946
Flurbiprofen sodium .3 mg/mL · Solution/ drops · Ophthalmic · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-3946-0 | 50090394600 | 1 BOTTLE, DROPPER in 1 CARTON (50090-3946-0) / 2.5 mL in 1 BOTTLE, DROPPERMarketed from Dec 10, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Flurbiprofen Sodium
- Generic name (nonproprietary)
- flurbiprofen sodium
- Active ingredients
- Flurbiprofen sodium — .3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074447
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-3946_a30f8036-6f66-4ddd-9dfe-8b754d979099SPL ID a30f8036-6f66-4ddd-9dfe-8b754d979099SPL set ID 9243ed05-1f7b-43ee-82c3-572a4112ae09RxCUI 1243585UNII Z5B97MU9K4
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N450090394600followed by a unit qualifier and the quantityPackage 50090-3946-00. 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 Flurbiprofen Sodium Ophthalmic Solution is indicated for the inhibition of intraoperative miosis.
Excerpt only. Read the full label for complete information.
About NDC 50090-3946
- What is NDC 50090-3946?
- 50090-3946 is the product NDC for Flurbiprofen Sodium, Flurbiprofen sodium .3 mg/mL solution/ drops, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Flurbiprofen Sodium.
- What is the active ingredient?
- Flurbiprofen sodium.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Flurbiprofen Sodium?
- 3 other product NDCs are listed under this name. See all Flurbiprofen Sodium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Flurbiprofen Sodium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Flurbiprofen Sodium | Flurbiprofen sodium .3 mg/mL | Solution/ dropsOphthalmic | Amici Pharma, Inc. | 69292-722 | 69292-0722-25 |
| Flurbiprofen Sodium | Flurbiprofen sodium .3 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 63187-937 | 63187-0937-25 |
| Flurbiprofen Sodium | Flurbiprofen sodium .3 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-314 | 24208-0314-25 |
Other NDCs under ANDA 074447
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 |
|---|---|---|---|---|
| Flurbiprofen Sodium | Flurbiprofen sodium .3 mg/mL | Solution/ dropsOphthalmic | Amici Pharma, Inc. | 69292-722 |
| Flurbiprofen Sodium | Flurbiprofen sodium .3 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 63187-937 |
| Flurbiprofen Sodium | Flurbiprofen sodium .3 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-314 |