NDC codes

FDA NDC Directory
Product NDC (as listed)0338-9661Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00338-9661Add 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
0338-9661-6000338966160100 mL in 1 BAG (0338-9661-60)Marketed from Aug 9, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 016677
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 0338-9661_fa3c6492-94f3-471d-a1cb-e59fbf00b785SPL ID fa3c6492-94f3-471d-a1cb-e59fbf00b785SPL set ID 958d35f0-6834-43be-a700-fa58f38b4c19RxCUI 1807631, 1807632, 1807633, 1807634, 1807639UNII 451W47IQ8X
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

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

N400338966160 followed by a unit qualifier and the quantity

Package 00338-9661-60. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 016677

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 016677
ProductStrengthForm · routeLabelerProduct NDC
Sodium ChlorideSodium chloride 9 g/1000mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-0049
Sodium ChlorideSodium chloride 9 g/1000mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-9543
Sodium ChlorideSodium chloride 9 g/1000mLInjection, SolutionIntravenousSportpharm LLC85766-059
Sodium ChlorideSodium chloride 9 g/1000mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-9657
Sodium ChlorideSodium chloride 9 g/1000mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-9659
Sodium ChlorideSodium chloride 9 g/1000mLInjection, SolutionIntravenousProPharma Distribution84549-049
Sodium ChlorideSodium chloride 9 g/1000mLInjection, SolutionIntravenousBaxter Healthcare Corporation0338-9663

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