Over-the-counter drug · OTC MONOGRAPH DRUG
PurPrep (Povidone iodine and isopropyl alcohol) NDC 54365-014
Isopropyl alcohol 725 mg/mL; Povidone-iodine 8.3 mg/mL · Sponge · Topical · CareFusion 213 LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54365-014-41 | 5436500144154365001441 | 1 APPLICATOR in 1 POUCH (54365-014-41) / 10.5 mL in 1 APPLICATORMarketed from May 21, 2020 | |
| 54365-014-42 | 5436500144254365001442 | 1 APPLICATOR in 1 POUCH (54365-014-42) / 26 mL in 1 APPLICATORMarketed from Apr 9, 2020 |
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)
- PurPrep
- Generic name (nonproprietary)
- povidone iodine and isopropyl alcohol
- Active ingredients
- Isopropyl alcohol — 725 mg/mLPovidone-iodine — 8.3 mg/mL
- Dosage form
- Sponge
- Route
- Topical
- Labeler
- CareFusion 213 LLCNDC labeler code 54365
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication 505G(a)(3)
- Marketing start
- Listing expires
- Identifiers
- Product ID 54365-014_40add5c5-68aa-96f9-e063-6294a90a7282SPL ID 40add5c5-68aa-96f9-e063-6294a90a7282SPL set ID a1c6e118-7861-c8d0-e053-2995a90aeaaaRxCUI 1052725UNII ND2M416302, 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N454365001441followed by a unit qualifier and the quantityPackage 54365-0014-41. 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)
Use for the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.
Excerpt only. Read the full label for complete information.
About NDC 54365-014
- What is NDC 54365-014?
- 54365-014 is the product NDC for PurPrep, Isopropyl alcohol 725 mg/mL; Povidone-iodine 8.3 mg/mL sponge, listed with the FDA by CareFusion 213 LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PurPrep (Povidone iodine and isopropyl alcohol).
- What is the active ingredient?
- Isopropyl alcohol, Povidone-iodine.
- Who is the labeler?
- CareFusion 213 LLC, NDC labeler code 54365. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for PurPrep?
- 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.
Other NDCs under 505G(a)(3)
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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