Prescription drug · ANDA
Sodium Bicarbonate NDC 81665-200
Sodium bicarbonate 84 mg/mL · Injection, Solution · Intravenous · OMNIVIUM PHARMACEUTICALS LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81665-200-05 | 8166502000581665020005 | 20 VIAL in 1 CARTON (81665-200-05) / 50 mL in 1 VIAL (81665-200-01)Marketed from Jun 16, 2023 | |
| 81665-200-25 | 8166502002581665020025 | 25 VIAL in 1 CARTON (81665-200-25) / 50 mL in 1 VIAL (81665-200-01)Marketed from Jun 16, 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)
- Sodium Bicarbonate
- Generic name (nonproprietary)
- sodium bicarbonate
- Active ingredients
- Sodium bicarbonate — 84 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- OMNIVIUM PHARMACEUTICALS LLC.NDC labeler code 81665
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216364
- Marketing start
- Listing expires
- Other FDA classes
- Alkalinizing Activity (Mechanism)
- Identifiers
- Product ID 81665-200_ada1be4a-11f4-4850-b98c-88e6ef02cd31SPL ID ada1be4a-11f4-4850-b98c-88e6ef02cd31SPL set ID aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbcRxCUI 1868486UNII 8MDF5V39QOUPC 0381665200012
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.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N481665020005followed by a unit qualifier and the quantityPackage 81665-0200-05. 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 Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate …
Excerpt only. Read the full label for complete information.
About NDC 81665-200
- What is NDC 81665-200?
- 81665-200 is the product NDC for Sodium Bicarbonate, Sodium bicarbonate 84 mg/mL injection, solution, listed with the FDA by OMNIVIUM PHARMACEUTICALS LLC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Bicarbonate.
- What is the active ingredient?
- Sodium bicarbonate.
- Who is the labeler?
- OMNIVIUM PHARMACEUTICALS LLC., NDC labeler code 81665. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Bicarbonate?
- 55 other product NDCs are listed under this name. See all Sodium Bicarbonate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium Bicarbonate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| sodium bicarbonate | Sodium bicarbonate 12.6 mg/mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0822 | 00338-0822-10 |
| Sodium Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Milla Pharmaceuticals Inc. | 71357-004 | 71357-0004-10 |
| Sodium Bicarbonate | Sodium bicarbonate 12.6 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-2613 | 80830-2613-02 |
| Sodium Bicarbonatesodium bicarbonate, injection | Sodium bicarbonate 84 mg/mL | SolutionIntravenous | Civica, Inc. | 72572-200 | 72572-0200-20 |
| Sodium Bicarbonate | Sodium bicarbonate 2.6 g/2.6g | PowderOral | Vitamex USA, Corp | 69469-100 | 69469-0100-04 |
| Sodium Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-2305 | 80830-2305-02 |
| Sodium Bicarbonate | Sodium bicarbonate 42 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-083 | 63323-0083-05 |
| Sodium Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-089 | 63323-0089-50 |
| Sodium Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Glenmark Pharmaceuticals Inc., USA | 68462-951 | 68462-0951-65 |
| Sodium Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC. | 71872-7376 | 71872-7376-01 |
Other NDCs under ANDA 216364
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 |
|---|---|---|---|---|
| Sodium Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Bryant Ranch Prepack | 72162-2314 |