NDC codes

FDA NDC Directory
Product NDC (as listed)71288-040Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71288-0040Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
71288-040-6571288004065712880040656 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.

How CPT relates to drug billing

NDC on a medical claim

N471288004065 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

FDA NDC Directory listings under NDA 211673
ProductStrengthForm · routeLabelerProduct NDC
Xenletalefamulin acetateLefamulin acetate 150 mg/15mLInjection, SolutionIntravenousMeitheal Pharmaceuticals Inc.71288-039

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