Prescription drug · ANDA
Dorzolamide Hydrochloride Ophthalmic (Dorzolamide hydrochloride) NDC 50090-4882
Dorzolamide hydrochloride 20 mg/mL · Solution/ drops · Ophthalmic · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-4882-0 | 50090488200 | 1 BOTTLE in 1 CARTON (50090-4882-0) / 10 mL in 1 BOTTLEMarketed from Feb 11, 2020 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Active ingredients
- Dorzolamide hydrochloride — 20 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- A-S Medication SolutionsNDC labeler code 50090
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204778
- Marketing start
- Listing expires
- Other FDA classes
- Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 50090-4882_20057f70-1994-43ac-b9f9-0dc7d27a6d6bSPL ID 20057f70-1994-43ac-b9f9-0dc7d27a6d6bSPL set ID fa4b8802-3271-48a4-8a91-229ebc72f570RxCUI 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
N450090488200followed by a unit qualifier and the quantityPackage 50090-4882-00. 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 50090-4882
- What is NDC 50090-4882?
- 50090-4882 is the product NDC for Dorzolamide Hydrochloride Ophthalmic, Dorzolamide hydrochloride 20 mg/mL solution/ drops, listed with the FDA by A-S Medication Solutions. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dorzolamide Hydrochloride Ophthalmic (Dorzolamide Hydrochloride).
- What is the active ingredient?
- Dorzolamide hydrochloride.
- Who is the labeler?
- A-S Medication Solutions, NDC labeler code 50090. 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.
Related NDCs: other Dorzolamide Hydrochloride Ophthalmic 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 Ophthalmic | Dorzolamide hydrochloride 20 mg/mL | SolutionOphthalmic | Florida Pharmaceutical Products, LLC | 71921-400 | 71921-0400-10 |
Other NDCs under ANDA 204778
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 Solutiondorzolamide hydrochloride | Dorzolamide hydrochloride 20 mg/mL | Solution/ dropsOphthalmic | Micro Labs Limited | 42571-141 |