NDC codes

FDA NDC Directory
Product NDC (as listed)0023-9277Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00023-9277Add 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
0023-9277-05000239277051 BOTTLE, DROPPER in 1 CARTON (0023-9277-05) / 5 mL in 1 BOTTLE, DROPPERMarketed from Aug 19, 2003

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 Ls
Generic name (nonproprietary)
ketorolac tromethamine
Active ingredients
Ketorolac tromethamine — 4 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 021528
Marketing start
Listing expires
Other FDA classes
Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
Identifiers
Product ID 0023-9277_15504a86-2bf2-470a-ad3d-99132d07d42dSPL ID 15504a86-2bf2-470a-ad3d-99132d07d42dSPL set ID 4fad0873-f79c-4f07-9fac-5060be6b38feRxCUI 860103, 860105UNII 4EVE5946BQUPC 0300239277052
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

N400023927705 followed by a unit qualifier and the quantity

Package 00023-9277-05. 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 LS ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. ACULAR LS ophthalmic solution is a nonsteroidal, anti-inflammatory drug (NSAID) indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0023-9277

What is NDC 0023-9277?
0023-9277 is the product NDC for Acular Ls (ketorolac tromethamine), Ketorolac tromethamine 4 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 Ls (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 Ls?
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.

Other NDCs under NDA 021528

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

FDA NDC Directory listings under NDA 021528
ProductStrengthForm · routeLabelerProduct NDC
Ketorolac TromethamineKetorolac tromethamine 4 mg/mLSolution/ dropsOphthalmicA-S Medication Solutions50090-3550
Ketorolac TromethamineKetorolac tromethamine 4 mg/mLSolution/ dropsOphthalmicPacific Pharma, Inc.60758-773

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