What is NDC 69315-304?

69315-304 is the product NDC for Dorzolamide hydrochloride, Dorzolamide hydrochloride 20 mg/mL solution, listed with the FDA by Leading Pharma, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

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 hydrochloride?

9 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dorzolamide hydrochloride NDC 69315-304

NDC codes

FDA NDC Directory

Product NDC (as listed)69315-304Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69315-0304Add 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
69315-304-05	69315030405	1 BOTTLE in 1 CARTON (69315-304-05) / 5 mL in 1 BOTTLEMarketed from Dec 1, 2019
69315-304-10	69315030410	1 BOTTLE in 1 CARTON (69315-304-10) / 10 mL in 1 BOTTLEMarketed from Dec 1, 2019

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 hydrochloride
Generic name (nonproprietary): dorzolamide hydrochloride
Active ingredients: Dorzolamide hydrochloride — 20 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 205294
Marketing start: Dec 1, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers: Product ID 69315-304_74ba8267-62eb-4b2e-a349-400d998a8eb8SPL ID 74ba8267-62eb-4b2e-a349-400d998a8eb8SPL set ID 7d4cb6cd-86d0-41d9-baa9-bca0fa7b0694RxCUI 310015UNII QZO5366EW7UPC 0369315304105, 0369315304051
Pharmacologic class: Carbonic Anhydrase Inhibitor

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

N469315030405 followed by a unit qualifier and the quantity

Package 69315-0304-05. 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 24, 2024.

Indications (excerpt from the label)

Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. (1) Dorzolamide Hydrochloride Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69315-304

What is NDC 69315-304?: 69315-304 is the product NDC for Dorzolamide hydrochloride, Dorzolamide hydrochloride 20 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 hydrochloride.
What is the active ingredient?: Dorzolamide hydrochloride.
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 hydrochloride?: 9 other product NDCs are listed under this name. See all Dorzolamide hydrochloride NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Dorzolamide hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Sagent Pharmaceuticals	25021-006	25021-0006-10
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Somerset Therapeutics, LLC	70069-501	70069-0501-01
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	SolutionOphthalmic	Advagen Pharma Ltd.	72888-077	72888-0077-15
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	SolutionOphthalmic	FOSUN PHARMA USA INC	72266-197	72266-0197-01
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	SolutionOphthalmic	Gland Pharma Limited	68083-489	68083-0489-01
Dorzolamide Hydrochloridedorzolamide	Dorzolamide hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Indoco Remedies Limited	14445-404	14445-0404-10
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Limited	46708-519	46708-0519-10
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-519	62332-0519-10
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Sandoz Inc	61314-019	61314-0019-10