Prescription drug · ANDA
Dorzolamide Hydrochloride and Timolol Maleate NDC 65862-946
Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL · Solution/ drops · Ophthalmic · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65862-946-01 | 6586209460165862094601 | 1 BOTTLE, DROPPER in 1 CARTON (65862-946-01) / 10 mL in 1 BOTTLE, DROPPERMarketed 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 and Timolol Maleate
- Generic name (nonproprietary)
- dorzolamide hydrochloride and timolol maleate
- Active ingredients
- Dorzolamide hydrochloride — 20 mg/mLTimolol maleate — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 65862
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207629
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 65862-946_f322a8a9-c2e2-4e7a-82b8-070c88e763b8SPL ID f322a8a9-c2e2-4e7a-82b8-070c88e763b8SPL set ID 2d5dcaa5-97ee-40c3-aa29-fcfb91fb78e1RxCUI 1923432UNII QZO5366EW7, P8Y54F701RUPC 0365862946010
- 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
N465862094601followed by a unit qualifier and the quantityPackage 65862-0946-01. 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 65862-946
- What is NDC 65862-946?
- 65862-946 is the product NDC for Dorzolamide Hydrochloride and Timolol Maleate, Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL solution/ drops, listed with the FDA by Aurobindo Pharma 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.
- What is the active ingredient?
- Dorzolamide hydrochloride, Timolol maleate.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 65862. 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?
- 11 other product NDCs are listed under this name. See all Dorzolamide Hydrochloride and Timolol Maleate 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 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 | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Ingenus Pharmaceuticals, LLC | 50742-323 | 50742-0323-60 |
| Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Gland Pharma Limited | 68083-490 | 68083-0490-01 |
| Dorzolamide Hydrochloride And Timolol Maleatedorzolamide hydrochloride and timolol maleate preservative free | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Micro Labs Limited | 42571-382 | 42571-0382-2742571-0382-73 |
| Dorzolamide Hydrochloride And Timolol Maleatedorzolamide hydrochloride and timolol maleate preservative free | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Bryant Ranch Prepack | 72162-2387 | 72162-2387-06 |
| DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | SolutionOphthalmic | Somerset Therapeutics, LLC | 70069-051 | 70069-0051-01 |
| Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Akorn | 50383-261 | — |
| Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | SolutionOphthalmic | Sandoz Inc | 61314-030 | 61314-0030-0161314-0030-02 |
| Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | SolutionOphthalmic | Bryant Ranch Prepack | 72162-2184 | 72162-2184-02 |
| Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-486 | 24208-0486-0524208-0486-10 |
| Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-6371 | 50090-6371-00 |