Prescription drug · NDA
Citric Buffered Normal Saline (Anhydrous citric acid) NDC 71288-040
Anhydrous citric acid 166 mg/270mL · Injection, Solution · Intravenous · Meitheal Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71288-040-65 | 7128800406571288004065 | 6 BAG in 1 CARTON (71288-040-65) / 270 mL in 1 BAG (71288-040-64)Marketed from Sep 9, 2019 |
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)
- Citric Buffered Normal Saline
- Generic name (nonproprietary)
- anhydrous citric acid
- Active ingredients
- Anhydrous citric acid — 166 mg/270mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Meitheal Pharmaceuticals Inc.NDC labeler code 71288
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211673
- Marketing start
- Listing expires
- Other FDA classes
- Acidifying Activity (Mechanism)Calcium Chelating Activity (Mechanism)Decreased Coagulation Factor Activity (Physiologic effect)
- Identifiers
- Product ID 71288-040_b9951406-492b-4420-89cc-24fd655824b3SPL ID b9951406-492b-4420-89cc-24fd655824b3SPL set ID eb972ea8-7502-422e-84bb-66cb8e93ca06RxCUI 2198948, 2198953, 2198961, 2198966, 2747671, 2747672UNII HDN0B924X4, XF417D3PSL
- Pharmacologic class
- Anti-coagulant; Calculi Dissolution Agent
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
N471288004065followed by a unit qualifier and the quantityPackage 71288-0040-65. 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)
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. ( 1.1 ) To reduce the development of drug resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Community-Acquired Bacterial Pneumonia (CABP) XENLETA is indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae , Staphylococcus aureus (methicillin-sus…
Excerpt only. Read the full label for complete information.
About NDC 71288-040
- What is NDC 71288-040?
- 71288-040 is the product NDC for Citric Buffered Normal Saline (anhydrous citric acid), Anhydrous citric acid 166 mg/270mL injection, solution, listed with the FDA by Meitheal Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Citric Buffered Normal Saline (Anhydrous citric acid).
- What is the active ingredient?
- Anhydrous citric acid.
- Who is the labeler?
- Meitheal Pharmaceuticals Inc., NDC labeler code 71288. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Citric Buffered Normal Saline?
- 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.
Other NDCs under NDA 211673
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 |
|---|---|---|---|---|
| Xenletalefamulin acetate | Lefamulin acetate 150 mg/15mL | Injection, SolutionIntravenous | Meitheal Pharmaceuticals Inc. | 71288-039 |