What is NDC 61314-238?

61314-238 is the product NDC for Carteolol Hydrochloride, Carteolol hydrochloride 10 mg/mL solution, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Carteolol Hydrochloride?

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.

Carteolol Hydrochloride NDC 61314-238

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-238Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0238Add 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 NDC	11-digit (billing)	Package
61314-238-05	6131402380561314023805	5 mL in 1 BOTTLE, PLASTIC (61314-238-05)Marketed from Jan 5, 2000
61314-238-10	6131402381061314023810	10 mL in 1 BOTTLE, PLASTIC (61314-238-10)Marketed from Jan 5, 2000
61314-238-15	6131402381561314023815	15 mL in 1 BOTTLE, PLASTIC (61314-238-15)Marketed from Jan 5, 2000

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): Carteolol Hydrochloride
Generic name (nonproprietary): carteolol hydrochloride
Active ingredients: Carteolol hydrochloride — 10 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Sandoz IncNDC labeler code 61314
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075476
Marketing start: Jan 5, 2000
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)
Identifiers: Product ID 61314-238_c89793f0-318b-4481-8fc0-e9cb0dcc5244SPL ID c89793f0-318b-4481-8fc0-e9cb0dcc5244SPL set ID 571fe550-399d-4296-835c-37aa1ab9b409RxCUI 978573UNII 4797W6I0T4
Pharmacologic class: beta-Adrenergic Blocker

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

N461314023805 followed by a unit qualifier and the quantity

Package 61314-0238-05. 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 Apr 1, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Carteolol Hydrochloride Ophthalmic Solution 1% has been shown to be effective in lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma and intraocular hypertension. It may be used alone or in combination with other intraocular pressure lowering medications.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61314-238

What is NDC 61314-238?: 61314-238 is the product NDC for Carteolol Hydrochloride, Carteolol hydrochloride 10 mg/mL solution, listed with the FDA by Sandoz Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Carteolol Hydrochloride.
What is the active ingredient?: Carteolol hydrochloride.
Who is the labeler?: Sandoz Inc, NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Carteolol Hydrochloride?: 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.