Prescription drug · ANDA
Sky Oral Rinse (Chlorhexidine gluconate) NDC 63739-052
Chlorhexidine gluconate 1.2 mg/mL · Rinse · Oral · McKesson
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63739-052-57 | 6373900525763739005257 | 600 mL in 1 PACKAGE (63739-052-57)Marketed from Feb 15, 2021 | |
| 63739-052-69 | 6373900526963739005269 | 1500 mL in 1 PACKAGE (63739-052-69)Marketed from Feb 15, 2021 | |
| 63739-052-74 | 6373900527463739005274 | 15 mL in 1 CUP, UNIT-DOSE (63739-052-74)Marketed from Feb 15, 2021 |
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)
- Sky Oral Rinse
- Generic name (nonproprietary)
- chlorhexidine gluconate
- Active ingredients
- Chlorhexidine gluconate — 1.2 mg/mL
- Dosage form
- Rinse
- Route
- Oral
- Labeler
- McKessonNDC labeler code 63739
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077789
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 63739-052_e99683de-d0a4-373b-e053-2a95a90ac808SPL ID e99683de-d0a4-373b-e053-2a95a90ac808SPL set ID b479c166-899b-0565-e053-2995a90a2094RxCUI 834127UNII MOR84MUD8E
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
N463739005257followed by a unit qualifier and the quantityPackage 63739-0052-57. 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)
INDICATION Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.
Excerpt only. Read the full label for complete information.
About NDC 63739-052
- What is NDC 63739-052?
- 63739-052 is the product NDC for Sky Oral Rinse (chlorhexidine gluconate), Chlorhexidine gluconate 1.2 mg/mL rinse, listed with the FDA by McKesson. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sky Oral Rinse (Chlorhexidine Gluconate).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- McKesson, NDC labeler code 63739. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sky Oral Rinse?
- 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 ANDA 077789
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 |
|---|---|---|---|---|
| Acclean Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Xttrium Laboratories, Inc. | 0116-4075 |
| Acclean Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Xttrium Laboratories, Inc. | 0116-6720 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate .12 mg/mL | LiquidOral | Xttrium Laboratories, Inc. | 0116-0101 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-0175 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-0301 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-1999 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-2001 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Xttrium Laboratories, Inc. | 0116-6000 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseDental | Major Pharmaceuticals | 0904-7035 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Atlantic Biologicals Corps. | 17856-2001 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | ATLANTIC BIOLOGICALS CORP. | 17856-2002 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | A-S Medication Solutions | 50090-0722 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Medline Industries, LP | 53329-301 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Den-mat Holdings, Llc | 59883-175 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Proficient Rx LP | 63187-685 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Darby Dental Supply, LLC | 66467-2560 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Benco Dental | 66975-600 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | NuCare Pharmaceuticals,Inc. | 68071-1837 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Preferred Pharmaceuticals, Inc. | 68788-9546 |
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | REMEDYREPACK INC. | 70518-4494 |
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