Prescription drug · ANDA
Sodium Chloride NDC 76297-001
Sodium chloride 9 g/1000mL · Injection, Solution · Intravenous · LABORATORIOS GRIFOLS SA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76297-001-01 | 76297000101 | 20 BAG in 1 CARTON (76297-001-01) / 500 mL in 1 BAG (76297-001-02)Marketed from May 25, 2017 | |
| 76297-001-11 | 76297000111 | 115 BAG in 1 CARTON (76297-001-11) / 50 mL in 1 BAG (76297-001-12)Marketed from Dec 1, 2018 | |
| 76297-001-21 | 76297000121 | 70 BAG in 1 CARTON (76297-001-21) / 100 mL in 1 BAG (76297-001-22)Marketed from Dec 1, 2018 | |
| 76297-001-31 | 76297000131 | 28 BAG in 1 CARTON (76297-001-31) / 250 mL in 1 BAG (76297-001-32)Marketed from Dec 1, 2018 | |
| 76297-001-41 | 76297000141 | 10 BAG in 1 CARTON (76297-001-41) / 1000 mL in 1 BAG (76297-001-42)Marketed from Mar 1, 2019 | |
| 76297-001-51 | 76297000151 | 90 BAG in 1 CARTON (76297-001-51) / 50 mL in 1 BAG (76297-001-52)Marketed from Aug 6, 2022 | |
| 76297-001-61 | 76297000161 | 50 BAG in 1 CARTON (76297-001-61) / 100 mL in 1 BAG (76297-001-62)Marketed from Aug 6, 2022 | |
| 76297-001-71 | 76297000171 | 32 BAG in 1 CARTON (76297-001-71) / 250 mL in 1 BAG (76297-001-72)Marketed from Aug 6, 2022 | |
| 76297-001-81 | 76297000181 | 24 BAG in 1 CARTON (76297-001-81) / 500 mL in 1 BAG (76297-001-82)Marketed from Aug 6, 2022 |
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 Chloride
- Generic name (nonproprietary)
- sodium chloride
- Active ingredients
- Sodium chloride — 9 g/1000mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- LABORATORIOS GRIFOLS SA
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207956
- Marketing start
- Listing expires
- Identifiers
- Product ID 76297-001_9b6fabaf-241d-4f33-9dc4-9eee0603804cSPL ID 9b6fabaf-241d-4f33-9dc4-9eee0603804cSPL set ID eb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadfRxCUI 1807631, 1807632, 1807633, 1807634, 1807639UNII 451W47IQ8X
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
N476297000101followed by a unit qualifier and the quantityPackage 76297-0001-01. 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 Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207956
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 Chloride | Sodium chloride 9 g/1000mL | Injection, SolutionIntravenous | CODAN US CORPORATION | 81826-001 |
| 0.9% Sodium Chloride | Sodium chloride 9 g/1000mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1609 |
| Sodium Chloride | Sodium chloride 9 g/1000mL | Injection, SolutionIntravenous | SOLA Pharmaceuticals, LLC | 70512-841 |
| Sodium Chloride | Sodium chloride 9 g/1000mL | Injection, SolutionIntravenous | Nextgen Pharmaceuticals LLC | 79672-613 |