NDC codes

FDA NDC Directory
Product NDC (as listed)69344-144Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69344-0144Add 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
69344-144-43693440144435 CARTON in 1 CARTON (69344-144-43) / 1 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)Marketed from Apr 26, 2011
69344-144-53693440144531 BOTTLE, SPRAY in 1 CARTON (69344-144-53) / 8 SPRAY, METERED in 1 BOTTLE, SPRAY (69344-144-63)Marketed from Mar 2, 2022

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)
Sprix
Generic name (nonproprietary)
ketorolac tromethamine
Active ingredients
Ketorolac tromethamine — 15.75 mg/1
Dosage form
Spray, Metered
Route
Nasal
Labeler
Zyla Life Sciences US LLCNDC labeler code 69344
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022382
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 69344-144_6ec8c9cf-7780-4bb1-8233-8a4e28ab43f0SPL ID 6ec8c9cf-7780-4bb1-8233-8a4e28ab43f0SPL set ID 97005a1c-167e-4676-bae7-e49b38c36f9eRxCUI 1797855, 1797857UNII 4EVE5946BQ
Pharmacologic class
Cyclooxygenase Inhibitor; Nonsteroidal Anti-inflammatory Drug

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 HCPCS code in Med-Code's directory. Nasal products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N469344014443 followed by a unit qualifier and the quantity

Package 69344-0144-43. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

SPRIX is indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. Limitations of Use Sprix is not for use in pediatric patients less than 2 years of age. SPRIX is a nonsteroidal anti-inflammatory drug indicated in adult patients for the short term (up to 5 days) management of moderate to moderately severe pain that requires analgesia at the opioid level. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69344-144

What is NDC 69344-144?
69344-144 is the product NDC for Sprix (ketorolac tromethamine), Ketorolac tromethamine 15.75 mg/1 spray, metered, listed with the FDA by Zyla Life Sciences US LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Sprix (Ketorolac tromethamine).
What is the active ingredient?
Ketorolac tromethamine.
Who is the labeler?
Zyla Life Sciences US LLC, NDC labeler code 69344. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sprix?
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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