Prescription drug · NDA
Betadine (Povidone-iodine) NDC 0065-0411
Povidone-iodine 5 mg/mL · Solution · Ophthalmic · Alcon Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0065-0411-30 | 0006504113000065041130 | 1 BOTTLE in 1 CARTON (0065-0411-30) / 30 mL in 1 BOTTLEMarketed from Apr 1, 2000 |
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)
- Betadine
- Generic name (nonproprietary)
- povidone-iodine
- Active ingredients
- Povidone-iodine — 5 mg/mL
- Dosage form
- Solution
- Route
- Ophthalmic
- Labeler
- Alcon Laboratories, Inc.NDC labeler code 0065
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 018634
- Marketing start
- Listing expires
- Identifiers
- Product ID 0065-0411_45bf2066-cfd2-48ef-acf9-b590c69b83d8SPL ID 45bf2066-cfd2-48ef-acf9-b590c69b83d8SPL set ID b026de1b-9949-4557-ac49-c7b0038c24cdRxCUI 312570, 1149663UNII 85H0HZU99M
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
N400065041130followed by a unit qualifier and the quantityPackage 00065-0411-30. 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: BETADINE* 5% Sterile Ophthalmic Prep Solution for the eye is indicated for prepping of the periocular region (lids, brow, and cheek) and irrigation of the ocular surface (cornea, conjunctiva, and palpebral fornices).
Excerpt only. Read the full label for complete information.
About NDC 0065-0411
- What is NDC 0065-0411?
- 0065-0411 is the product NDC for Betadine (povidone-iodine), Povidone-iodine 5 mg/mL solution, listed with the FDA by Alcon Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Betadine (Povidone-iodine).
- What is the active ingredient?
- Povidone-iodine.
- Who is the labeler?
- Alcon Laboratories, Inc., NDC labeler code 0065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Betadine?
- 2 other product NDCs are listed under this name. See all Betadine NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Betadine products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Betadinepovidone-iodine | Povidone-iodine 100 mg/mL | SolutionTopical | Atlantis Consumer Healthcare, Inc. | 67618-190 | 67618-0190-0167618-0190-0367618-0190-25+1 more |
| Betadinepovidone-iodine | Povidone-iodine 5 mg/mL | SprayTopical | Atlantis Consumer Healthcare, Inc. | 67618-192 | 67618-0192-03 |