Prescription drug · ANDA
Dorzolamide Hydrochloride Ophthalmic Solution (Dorzolamide hydrochloride) NDC 42571-141
Dorzolamide hydrochloride 20 mg/mL · Solution/ drops · Ophthalmic · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-141-26 | 4257101412642571014126 | 1 BOTTLE in 1 CARTON (42571-141-26) / 10 mL in 1 BOTTLEMarketed from Nov 11, 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 Ophthalmic Solution
- Generic name (nonproprietary)
- dorzolamide hydrochloride
- Active ingredients
- Dorzolamide hydrochloride — 20 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Micro Labs LimitedNDC labeler code 42571
- 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 42571-141_2b30c4d1-0a5d-3ad8-e063-6394a90a4acbSPL ID 2b30c4d1-0a5d-3ad8-e063-6394a90a4acbSPL set ID 4698e4e1-c5f6-4db1-9328-74464a85afeaRxCUI 310015UNII QZO5366EW7UPC 0342571141264
- 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
N442571014126followed by a unit qualifier and the quantityPackage 42571-0141-26. 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 42571-141
- What is NDC 42571-141?
- 42571-141 is the product NDC for Dorzolamide Hydrochloride Ophthalmic Solution, Dorzolamide hydrochloride 20 mg/mL solution/ drops, listed with the FDA by Micro Labs Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dorzolamide Hydrochloride Ophthalmic Solution (Dorzolamide Hydrochloride).
- What is the active ingredient?
- Dorzolamide hydrochloride.
- Who is the labeler?
- Micro Labs Limited, NDC labeler code 42571. 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 Solution?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 Ophthalmicdorzolamide hydrochloride | Dorzolamide hydrochloride 20 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-4882 |