Prescription drug · NDA
Acular (Ketorolac tromethamine) NDC 0023-2181
Ketorolac tromethamine 5 mg/mL · Solution/ drops · Ophthalmic · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0023-2181-05 | 00023218105 | 1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Dec 1, 1992 |
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)
- Acular
- Generic name (nonproprietary)
- ketorolac tromethamine
- Active ingredients
- Ketorolac tromethamine — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Allergan, Inc.NDC labeler code 0023
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019700
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 0023-2181_fb99e487-9880-4bb9-9271-7bf042a4f0f8SPL ID fb99e487-9880-4bb9-9271-7bf042a4f0f8SPL set ID c94644d3-7b64-4f3d-a0c7-12c77466a0fcRxCUI 860107, 860109UNII 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. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400023218105followed by a unit qualifier and the quantityPackage 00023-2181-05. 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)
ACULAR is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. ACULAR is a nonsteroidal anti-inflammatory drug (NSAID) indicated for: The temporary relief of ocular itching due to seasonal allergic conjunctivitis. ( 1 ) The treatment of inflammation following cataract surgery. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0023-2181
- What is NDC 0023-2181?
- 0023-2181 is the product NDC for Acular (ketorolac tromethamine), Ketorolac tromethamine 5 mg/mL solution/ drops, listed with the FDA by Allergan, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acular (Ketorolac Tromethamine).
- What is the active ingredient?
- Ketorolac tromethamine.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acular?
- 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.