What is NDC 69315-305?

69315-305 is the product NDC for Dorzolamide and Timolol, Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Dorzolamide hydrochloride, Timolol maleate.

Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Dorzolamide and Timolol?

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.

Dorzolamide and Timolol NDC 69315-305

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-305Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0305Add 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	Copy
69315-305-05	6931503050569315030505	1 BOTTLE, PLASTIC in 1 CARTON (69315-305-05) / 5 mL in 1 BOTTLE, PLASTICMarketed from May 18, 2017
69315-305-10	6931503051069315030510	1 BOTTLE, PLASTIC in 1 CARTON (69315-305-10) / 10 mL in 1 BOTTLE, PLASTICMarketed from May 18, 2017

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): Dorzolamide and Timolol
Generic name (nonproprietary): dorzolamide hydrochloride and timolol maleate ophthalmic solution
Active ingredients: Dorzolamide hydrochloride — 20 mg/mLTimolol maleate — 5 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Leading Pharma, LLCNDC labeler code 69315
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205295
Marketing start: May 18, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers: Product ID 69315-305_bb4ef754-0b95-4c0e-8131-7a81dc4f33d3SPL ID bb4ef754-0b95-4c0e-8131-7a81dc4f33d3SPL set ID c9ae08c5-275d-44b3-9d1e-5d8fedc21b96RxCUI 1923432UNII QZO5366EW7, P8Y54F701RUPC 0369315305058, 0369315305102
Pharmacologic class: Carbonic Anhydrase Inhibitor; 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

N469315030505 followed by a unit qualifier and the quantity

Package 69315-0305-05. 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 May 25, 2024.

Indications (excerpt from the label)

Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a combination of dorzolamide hydrochloride, a carbonic anhydrase inhibitor and timolol maleate, a beta-adrenergic receptor blocking agent indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers. The IOP-lowering of Dorzolamide hydrochloride and timolol maleate ophthalmic solution twice daily was slightly less than that seen with the concomitant administration of 0.5% timolol twice daily, and 2% dorzolamide three times daily. ( 1 ) Dorzolamide hydrochloride and timolol maleate ophthalmic solution is indic…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69315-305

What is NDC 69315-305?: 69315-305 is the product NDC for Dorzolamide and Timolol, Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dorzolamide and Timolol (Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution).
What is the active ingredient?: Dorzolamide hydrochloride, Timolol maleate.
Who is the labeler?: Leading Pharma, LLC, NDC labeler code 69315. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dorzolamide and Timolol?: 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.