Prescription drug · NDA
Konvomep (Omeprazole and sodium bicarbonate) NDC 65628-272
Kit · Azurity Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65628-272-03 | 6562802720365628027203 | 1 KIT in 1 CARTON (65628-272-03) * 150 mL in 1 BOTTLE (65628-270-05) * 300 mL in 1 BOTTLE (65628-270-10) * 150 mL in 1 BOTTLE (65628-271-05) * 300 mL in 1 BOTTLE (65628-271-10) * 90 mL in 1 BOTTLE (65628-271-03) * 90 mL in 1 BOTTLE (65628-270-03)Marketed from Feb 15, 2023 | |
| 65628-272-05 | 6562802720565628027205 | 1 KIT in 1 CARTON (65628-272-05) * 150 mL in 1 BOTTLE (65628-270-05) * 300 mL in 1 BOTTLE (65628-270-10) * 150 mL in 1 BOTTLE (65628-271-05) * 300 mL in 1 BOTTLE (65628-271-10) * 90 mL in 1 BOTTLE (65628-271-03) * 90 mL in 1 BOTTLE (65628-270-03)Marketed from Feb 15, 2023 | |
| 65628-272-10 | 6562802721065628027210 | 1 KIT in 1 CARTON (65628-272-10) * 150 mL in 1 BOTTLE (65628-270-05) * 300 mL in 1 BOTTLE (65628-270-10) * 150 mL in 1 BOTTLE (65628-271-05) * 300 mL in 1 BOTTLE (65628-271-10) * 90 mL in 1 BOTTLE (65628-271-03) * 90 mL in 1 BOTTLE (65628-270-03)Marketed from Feb 15, 2023 |
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)
- Konvomep
- Generic name (nonproprietary)
- omeprazole and sodium bicarbonate
- Dosage form
- Kit
- Labeler
- Azurity Pharmaceuticals, Inc.NDC labeler code 65628
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213593
- Marketing start
- Listing expires
- Identifiers
- Product ID 65628-272_461e360d-0e63-e7b5-e063-6294a90a17c8SPL ID 461e360d-0e63-e7b5-e063-6294a90a17c8SPL set ID 688ed6f1-d78a-4006-a682-57021cb38a3eRxCUI 2625144, 2625150UPC 0365628270106, 0365628271103
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N465628027203followed by a unit qualifier and the quantityPackage 65628-0272-03. 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)
KONVOMEP is indicated in adults for: short-term treatment (4 to 8 weeks) of active benign gastric ulcer. reduction of risk of upper gastrointestinal (GI) bleeding in critically ill adult patients. KONVOMEP is a combination of omeprazole, a proton pump inhibitor (PPI) and sodium bicarbonate, indicated in adults for: •Treatment of active benign gastric ulcer ( 1 ) •Reduction of risk of upper gastrointestinal (GI) bleeding in critically ill patients ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 65628-272
- What is NDC 65628-272?
- 65628-272 is the product NDC for Konvomep kit, listed with the FDA by Azurity Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Konvomep (Omeprazole and sodium bicarbonate).
- Who is the labeler?
- Azurity Pharmaceuticals, Inc., NDC labeler code 65628. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Konvomep?
- 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.