Prescription drug · ANDA
Dorzolamide Hydrochloride (Dorzolamide) NDC 14445-404
Dorzolamide hydrochloride 20 mg/mL · Solution/ drops · Ophthalmic · Indoco Remedies Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 14445-404-10 | 1444504041014445040410 | 1 BOTTLE, DISPENSING in 1 CARTON (14445-404-10) / 10 mL in 1 BOTTLE, DISPENSINGMarketed from May 14, 2021 |
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
- Active ingredients
- Dorzolamide hydrochloride — 20 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Indoco Remedies LimitedNDC labeler code 14445
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202053
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 14445-404_746e0cc7-7ea7-4090-acb3-69de5fe85be3SPL ID 746e0cc7-7ea7-4090-acb3-69de5fe85be3SPL set ID 462a61b2-1ec6-4d18-bc6b-fc03e027caa0RxCUI 310015UNII QZO5366EW7UPC 0314445404102
- 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
N414445040410followed by a unit qualifier and the quantityPackage 14445-0404-10. 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 14445-404
- What is NDC 14445-404?
- 14445-404 is the product NDC for Dorzolamide Hydrochloride (dorzolamide), Dorzolamide hydrochloride 20 mg/mL solution/ drops, listed with the FDA by Indoco Remedies Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dorzolamide Hydrochloride (Dorzolamide).
- What is the active ingredient?
- Dorzolamide hydrochloride.
- Who is the labeler?
- Indoco Remedies Limited, NDC labeler code 14445. 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 | 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 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 202053
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 Ophthalmic | Dorzolamide hydrochloride 20 mg/mL | SolutionOphthalmic | Florida Pharmaceutical Products, LLC | 71921-400 |