Prescription drug · ANDA
DASH Chlorhexidine Gluconate 0.12% Oral Rinse (Chlorhexidine gluconate 0.12% oral rinse) NDC 69339-138
Chlorhexidine gluconate 1.2 mg/mL · Liquid · Oral · Natco Pharma USA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69339-138-15 | 6933901381569339013815 | 15 mL in 1 CUP, UNIT-DOSE (69339-138-15)Marketed from Apr 25, 2018 | |
| 69339-138-17 | 6933901381769339013817 | 600 mL in 1 DOSE PACK (69339-138-17)Marketed from Apr 25, 2018 | |
| 69339-138-19 | 6933901381969339013819 | 1500 mL in 1 DOSE PACK (69339-138-19)Marketed from Apr 25, 2018 |
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)
- DASH Chlorhexidine Gluconate 0.12% Oral Rinse
- Generic name (nonproprietary)
- chlorhexidine gluconate 0.12% oral rinse
- Active ingredients
- Chlorhexidine gluconate — 1.2 mg/mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Natco Pharma USA LLCNDC labeler code 69339
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 074291
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Cell Wall Integrity (Physiologic effect)
- Identifiers
- Product ID 69339-138_2e6b1725-1082-4541-9725-2fb49ae15817SPL ID 2e6b1725-1082-4541-9725-2fb49ae15817SPL set ID 12a11cd7-5087-4eb8-aa52-4fad402450f7RxCUI 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
N469339013815followed by a unit qualifier and the quantityPackage 69339-0138-15. 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 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 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 69339-138
- What is NDC 69339-138?
- 69339-138 is the product NDC for DASH Chlorhexidine Gluconate 0.12% Oral Rinse, Chlorhexidine gluconate 1.2 mg/mL liquid, listed with the FDA by Natco Pharma USA LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- DASH Chlorhexidine Gluconate 0.12% Oral Rinse (Chlorhexidine Gluconate 0.12% Oral Rinse).
- What is the active ingredient?
- Chlorhexidine gluconate.
- Who is the labeler?
- Natco Pharma USA LLC, NDC labeler code 69339. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for DASH Chlorhexidine Gluconate 0.12% Oral Rinse?
- 2 other product NDCs are listed under this name. See all DASH Chlorhexidine Gluconate 0.12% Oral Rinse NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other DASH Chlorhexidine Gluconate 0.12% Oral Rinse products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| DASH Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Cardinal Health 107, LLC | 55154-1980 | 55154-1980-05 |
| DASH Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Cardinal Health 107, LLC | 55154-1981 | 55154-1981-05 |
Other NDCs under ANDA 074291
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 |
|---|---|---|---|---|
| Chlorhexidine Gluconate | Chlorhexidine gluconate 1.2 mg/mL | RinseOral | Lyne Laboratories, Inc. | 0374-5080 |
| DASH Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Cardinal Health 107, LLC | 55154-1980 |
| DASH Chlorhexidine Gluconate 0.12% Oral Rinsechlorhexidine gluconate 0.12% oral rinse | Chlorhexidine gluconate 1.2 mg/mL | LiquidOral | Cardinal Health 107, LLC | 55154-1981 |