What is NDC 71921-400?

71921-400 is the product NDC for Dorzolamide Hydrochloride Ophthalmic, Dorzolamide hydrochloride 20 mg/mL solution, listed with the FDA by Florida Pharmaceutical Products, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Florida Pharmaceutical Products, LLC, NDC labeler code 71921. 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 Ophthalmic?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dorzolamide Hydrochloride Ophthalmic NDC 71921-400

NDC codes

FDA NDC Directory

Product NDC (as listed)71921-400Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71921-0400Add 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
71921-400-10	7192104001071921040010	10 mL in 1 BOTTLE (71921-400-10)Marketed from May 7, 2025

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 Ophthalmic
Generic name (nonproprietary): dorzolamide hydrochloride ophthalmic
Active ingredients: Dorzolamide hydrochloride — 20 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Florida Pharmaceutical Products, LLCNDC labeler code 71921
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202053
Marketing start: May 7, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Carbonic Anhydrase Inhibitors (Mechanism)
Identifiers: Product ID 71921-400_dfe4a7f4-7ff1-4095-94e1-ef69a1ebe4a3SPL ID dfe4a7f4-7ff1-4095-94e1-ef69a1ebe4a3SPL set ID e4e6a5a8-f7be-4424-83f2-d6bb4d57443eRxCUI 310015UNII QZO5366EW7UPC 0371921400102
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

N471921040010 followed by a unit qualifier and the quantity

Package 71921-0400-10. 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 Jun 24, 2026.

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. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71921-400

What is NDC 71921-400?: 71921-400 is the product NDC for Dorzolamide Hydrochloride Ophthalmic, Dorzolamide hydrochloride 20 mg/mL solution, listed with the FDA by Florida Pharmaceutical Products, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Dorzolamide Hydrochloride Ophthalmic.
What is the active ingredient?: Dorzolamide hydrochloride.
Who is the labeler?: Florida Pharmaceutical Products, LLC, NDC labeler code 71921. 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 Ophthalmic?: 1 other product NDC are listed under this name. See all Dorzolamide Hydrochloride Ophthalmic 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 Ophthalmic NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Dorzolamide Hydrochloride Ophthalmicdorzolamide hydrochloride	Dorzolamide hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	A-S Medication Solutions	50090-4882	50090-4882-00

Other NDCs under ANDA 202053

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

FDA NDC Directory listings under ANDA 202053
Product	Strength	Form · route	Labeler	Product NDC
Dorzolamide Hydrochloridedorzolamide	Dorzolamide hydrochloride 20 mg/mL	Solution/ dropsOphthalmic	Indoco Remedies Limited	14445-404