NDC codes

FDA NDC Directory
Product NDC (as listed)62332-519Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62332-0519Add 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 NDC11-digit (billing)PackageCopy
62332-519-10623320519101 BOTTLE in 1 CARTON (62332-519-10) / 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 Inc.NDC labeler code 62332
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212639
Marketing start
Listing expires
Other FDA classes
Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers
Product ID 62332-519_3072620e-aa7a-4213-bfe6-5a59de392798SPL ID 3072620e-aa7a-4213-bfe6-5a59de392798SPL set ID 5ad43fd4-19f0-448f-97a8-625ada4cb147RxCUI 310015UNII QZO5366EW7UPC 0362332519101
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

N462332051910 followed by a unit qualifier and the quantity

Package 62332-0519-10. 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 .

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 62332-519

What is NDC 62332-519?
62332-519 is the product NDC for Dorzolamide Hydrochloride, Dorzolamide hydrochloride 20 mg/mL solution/ drops, listed with the FDA by Alembic Pharmaceuticals Inc.. 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 Inc., NDC labeler code 62332. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dorzolamide HydrochlorideDorzolamide hydrochloride 20 mg/mLSolution/ dropsOphthalmicSagent Pharmaceuticals25021-00625021-0006-10
Dorzolamide HydrochlorideDorzolamide hydrochloride 20 mg/mLSolution/ dropsOphthalmicSomerset Therapeutics, LLC70069-50170069-0501-01
Dorzolamide HydrochlorideDorzolamide hydrochloride 20 mg/mLSolutionOphthalmicAdvagen Pharma Ltd.72888-07772888-0077-15
Dorzolamide HydrochlorideDorzolamide hydrochloride 20 mg/mLSolutionOphthalmicFOSUN PHARMA USA INC72266-19772266-0197-01
Dorzolamide HydrochlorideDorzolamide hydrochloride 20 mg/mLSolutionOphthalmicGland Pharma Limited68083-48968083-0489-01
Dorzolamide HydrochloridedorzolamideDorzolamide hydrochloride 20 mg/mLSolution/ dropsOphthalmicIndoco Remedies Limited14445-40414445-0404-10
Dorzolamide hydrochlorideDorzolamide hydrochloride 20 mg/mLSolutionOphthalmicLeading Pharma, LLC69315-30469315-0304-0569315-0304-10
Dorzolamide HydrochlorideDorzolamide hydrochloride 20 mg/mLSolution/ dropsOphthalmicAlembic Pharmaceuticals Limited46708-51946708-0519-10
Dorzolamide HydrochlorideDorzolamide hydrochloride 20 mg/mLSolution/ dropsOphthalmicSandoz Inc61314-01961314-0019-10

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
ProductStrengthForm · routeLabelerProduct NDC
Dorzolamide HydrochlorideDorzolamide hydrochloride 20 mg/mLSolution/ dropsOphthalmicAlembic Pharmaceuticals Limited46708-519

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