Vaccine · BLA
Diluent (Sodium chloride) NDC 49281-912
Sodium chloride 4.5 mg/.5mL · Injection · Subcutaneous · Sanofi Vaccines US Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49281-912-05 | 4928109120549281091205 | 5 VIAL, SINGLE-DOSE in 1 PACKAGE (49281-912-05) / .6 mL in 1 VIAL, SINGLE-DOSE (49281-912-59)Marketed from May 22, 1953 | |
| 49281-912-10 | 4928109121049281091210 | 1 VIAL, MULTI-DOSE in 1 PACKAGE (49281-912-10) / 3 mL in 1 VIAL, MULTI-DOSE (49281-912-69)Marketed from May 22, 1953 |
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)
- Diluent
- Generic name (nonproprietary)
- sodium chloride
- Active ingredients
- Sodium chloride — 4.5 mg/.5mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- Sanofi Vaccines US Inc.NDC labeler code 49281
- Product type
- Vaccine
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103915
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)
- Identifiers
- Product ID 49281-912_619c17f6-1c56-4821-9ce4-cfdd5d381d86SPL ID 619c17f6-1c56-4821-9ce4-cfdd5d381d86
- Pharmacologic class
- Osmotic Laxative
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
Immunization administration (CPT 90460–90474)
Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.
- NDC on a medical claim
N449281091205followed by a unit qualifier and the quantityPackage 49281-0912-05. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 49281-912
- What is NDC 49281-912?
- 49281-912 is the product NDC for Diluent (sodium chloride), Sodium chloride 4.5 mg/.5mL injection, listed with the FDA by Sanofi Vaccines US Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Diluent (Sodium Chloride).
- What is the active ingredient?
- Sodium chloride.
- Who is the labeler?
- Sanofi Vaccines US Inc., NDC labeler code 49281. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Diluent?
- 1 other product NDC are listed under this name. See all Diluent NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diluent products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diluentwater solution | Water 1 mL/mL | InjectionIntravenous, Subcutaneous | Sandoz Inc | 0781-6021 | 00781-6021-94 |
Other NDCs under BLA 103915
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 |
|---|---|---|---|---|
| Yf-Vaxyellow fever virus strain 17d-204 live antigen | Yellow fever virus strain 17d-204 live antigen 4.74 [PFU]/.5mL | Injection, Powder, Lyophilized, For suspensionSubcutaneous | Sanofi Vaccines US Inc. | 49281-915 |