Prescription drug · ANDA
Dorzolamide Hydrochloride and Timolol Maleate ophthalmic Solution NDC 42571-147
dorzolamide hydrochloride and timolol maleate · Dorzolamide hydrochloride 22.3 mg/mL; Timolol maleate 6.8 mg/mL · Solution/ drops · Ophthalmic · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-147-26 | 4257101472642571014726 | 1 BOTTLE in 1 CARTON (42571-147-26) / 10 mL in 1 BOTTLEMarketed from Jun 15, 2020 |
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 and Timolol Maleate ophthalmic Solution
- Generic name (nonproprietary)
- dorzolamide hydrochloride and timolol maleate
- Active ingredients
- Dorzolamide hydrochloride — 22.3 mg/mLTimolol maleate — 6.8 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 204777
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 42571-147_22ff7483-50ec-42c6-e063-6394a90ae1faSPL ID 22ff7483-50ec-42c6-e063-6394a90ae1faSPL set ID f45cce05-fb47-4607-b68e-5a3d47e7235aRxCUI 1923432UNII QZO5366EW7, P8Y54F701RUPC 0342571147266
- Pharmacologic class
- Carbonic Anhydrase Inhibitor; beta-Adrenergic Blocker
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
N442571014726followed by a unit qualifier and the quantityPackage 42571-0147-26. 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 and timolol maleate ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers (failed to achieve target IOP determined after multiple measurements over time). The IOP-lowering of dorzolamide hydrochloride and timolol maleate ophthalmic solution administered twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol administered twice a day and 2% dorzolamide administered three times a day [see Clinical Studies (14) ]. Dorzolamide hydrochloride and timolol maleate ophthalmic solution is a …
Excerpt only. Read the full label for complete information.
About NDC 42571-147
- What is NDC 42571-147?
- 42571-147 is the product NDC for Dorzolamide Hydrochloride and Timolol Maleate ophthalmic Solution, Dorzolamide hydrochloride 22.3 mg/mL; Timolol maleate 6.8 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 and Timolol Maleate ophthalmic Solution (Dorzolamide Hydrochloride and Timolol Maleate).
- What is the active ingredient?
- Dorzolamide hydrochloride, Timolol maleate.
- 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 and Timolol Maleate ophthalmic Solution?
- 3 other product NDCs are listed under this name. See all Dorzolamide Hydrochloride and Timolol Maleate ophthalmic Solution 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 and Timolol Maleate ophthalmic Solution 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 and Timolol Maleate Ophthalmic Solution | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Limited | 46708-553 | 46708-0553-10 |
| Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Alembic Pharmaceuticals Inc. | 62332-553 | 62332-0553-10 |
| Dorzolamide Hydrochloride and Timolol Maleate ophthalmic Solutiondorzolamide hydrochloride and timolol maleate | Dorzolamide hydrochloride 22.3 mg/mL; Timolol maleate 6.8 mg/mL | Solution/ dropsOphthalmic | Bryant Ranch Prepack | 72162-2381 | 72162-2381-02 |
Other NDCs under ANDA 204777
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 and Timolol Maleate ophthalmic Solutiondorzolamide hydrochloride and timolol maleate | Dorzolamide hydrochloride 22.3 mg/mL; Timolol maleate 6.8 mg/mL | Solution/ dropsOphthalmic | Bryant Ranch Prepack | 72162-2381 |