Prescription drug · ANDA
Dorzolamide Hydrochloride NDC 25021-006
Dorzolamide hydrochloride 20 mg/mL · Solution/ drops · Ophthalmic · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-006-10 | 2502100061025021000610 | 1 BOTTLE in 1 CARTON (25021-006-10) / 10 mL in 1 BOTTLEMarketed from Jan 15, 2026 |
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
- Sagent PharmaceuticalsNDC labeler code 25021
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215660
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 25021-006_1a198736-860b-4ea2-a5db-e6ca487441bfSPL ID 1a198736-860b-4ea2-a5db-e6ca487441bfSPL set ID 0246463c-6c24-4611-8e22-2d5254ace66aRxCUI 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
N425021000610followed by a unit qualifier and the quantityPackage 25021-0006-10. 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. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 25021-006
- What is NDC 25021-006?
- 25021-006 is the product NDC for Dorzolamide Hydrochloride, Dorzolamide hydrochloride 20 mg/mL solution/ drops, listed with the FDA by Sagent Pharmaceuticals. 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?
- Sagent Pharmaceuticals, NDC labeler code 25021. 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.
Related NDCs: other Dorzolamide Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 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 |
Other NDCs under ANDA 215660
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dorzolamide Hydrochloride | Dorzolamide hydrochloride 20 mg/mL | SolutionOphthalmic | Gland Pharma Limited | 68083-489 |
| Dorzolamide Hydrochloride | Dorzolamide hydrochloride 20 mg/mL | SolutionOphthalmic | FOSUN PHARMA USA INC | 72266-197 |