NDC codes

FDA NDC Directory
Product NDC (as listed)0338-0295Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00338-0295Add 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
0338-0295-47003380295473000 mL in 1 BAG (0338-0295-47)Marketed from May 30, 1980

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)
Sorbitol
Generic name (nonproprietary)
sorbitol
Active ingredients
Sorbitol — 30 g/1000mL
Dosage form
Irrigant
Route
Irrigation
Labeler
Baxter Healthcare CorporationNDC labeler code 0338
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 017863
Marketing start
Listing expires
Identifiers
Product ID 0338-0295_45450c96-48fb-457b-bd3d-db242c848474SPL ID 45450c96-48fb-457b-bd3d-db242c848474SPL set ID aea0b5a1-444b-4330-a3ce-26485dbbfe75RxCUI 313090UNII 506T60A25R

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.

NDC on a medical claim

N400338029547 followed by a unit qualifier and the quantity

Package 00338-0295-47. 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 3% Sorbitol Urologic Irrigating Solution is indicated for use as a urologic irrigating fluid with endoscopic instruments during transurethral procedures requiring distension, irrigation, and lavage of the urinary bladder. It may be used for lavage of an indwelling catheter to maintain patency.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0338-0295

What is NDC 0338-0295?
0338-0295 is the product NDC for Sorbitol, Sorbitol 30 g/1000mL irrigant, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sorbitol.
What is the active ingredient?
Sorbitol.
Who is the labeler?
Baxter Healthcare Corporation, NDC labeler code 0338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sorbitol?
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.

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