Prescription drug · NDA
Sprix (Ketorolac tromethamine) NDC 69344-144
Ketorolac tromethamine 15.75 mg/1 · Spray, Metered · Nasal · Zyla Life Sciences US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69344-144-43 | 69344014443 | 5 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 | |
| 69344-144-53 | 69344014453 | 1 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
N469344014443followed by a unit qualifier and the quantityPackage 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.
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.