What is NDC 46708-519?

46708-519 is the product NDC for Dorzolamide Hydrochloride, Dorzolamide hydrochloride 20 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 46708-519

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-519Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0519Add 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
46708-519-10	46708051910	1 BOTTLE in 1 CARTON (46708-519-10) / 10 mL in 1 BOTTLEMarketed from Aug 9, 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/ drops
Route: Ophthalmic
Labeler: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212639
Marketing start: Aug 9, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers: Product ID 46708-519_64e77f0a-fff5-4e24-9af2-38a14b9a4ef9SPL ID 64e77f0a-fff5-4e24-9af2-38a14b9a4ef9SPL set ID fb2e0729-b0bc-4c3f-9961-8bb38f84a032RxCUI 310015UNII QZO5366EW7
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

N446708051910 followed by a unit qualifier and the quantity

Package 46708-0519-10. 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 Aug 27, 2024.

Indications (excerpt from the label)

Dorzolamide hydrochloride ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Dorzolamide hydrochloride ophthalmic solution is a carbonic anhydrase inhibitor indicated for 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 46708-519

What is NDC 46708-519?: 46708-519 is the product NDC for Dorzolamide Hydrochloride, Dorzolamide hydrochloride 20 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Limited. It has 1 package NDC, 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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	SolutionOphthalmic	Leading Pharma, LLC	69315-304	69315-0304-0569315-0304-10
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

Other NDCs under ANDA 212639

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

FDA NDC Directory listings under ANDA 212639
Product	Strength	Form · route	Labeler	Product NDC
Dorzolamide Hydrochloride	Dorzolamide hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Alembic Pharmaceuticals Inc.	62332-519