Prescription drug · ANDA
Dorzolamide Hydrochloride And Timolol Maleate NDC 42571-382
dorzolamide hydrochloride and timolol maleate preservative free · Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL · Solution/ drops · Ophthalmic · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-382-27 | 4257103822742571038227 | 12 POUCH in 1 CARTON (42571-382-27) / 15 VIAL, SINGLE-USE in 1 POUCH / .2 mL in 1 VIAL, SINGLE-USEMarketed from Mar 23, 2022 | |
| 42571-382-73 | 4257103827342571038273 | 4 POUCH in 1 CARTON (42571-382-73) / 15 VIAL, SINGLE-USE in 1 POUCH (42571-382-71) / .2 mL in 1 VIAL, SINGLE-USEMarketed from Mar 23, 2022 |
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 preservative free
- Active ingredients
- Dorzolamide hydrochloride — 20 mg/mLTimolol maleate — 5 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 215936
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 42571-382_50aa565b-e11f-8176-e063-6294a90ab0b5SPL ID 50aa565b-e11f-8176-e063-6294a90ab0b5SPL set ID b0a1d984-efee-4751-9797-c09adc2d307dRxCUI 1922783UNII QZO5366EW7, P8Y54F701R
- 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
N442571038227followed by a unit qualifier and the quantityPackage 42571-0382-27. 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 preservative free 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 (14.1) ]. Dorzolamide hydrochloride and timolol maleate ophth…
Excerpt only. Read the full label for complete information.
About NDC 42571-382
- What is NDC 42571-382?
- 42571-382 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 Micro Labs Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dorzolamide Hydrochloride And Timolol Maleate (Dorzolamide hydrochloride and timolol maleate preservative free).
- 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?
- 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 | Bryant Ranch Prepack | 72162-2387 | 72162-2387-06 |
| Dorzolamide Hydrochloride and Timolol Maleate | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Aurobindo Pharma Limited | 65862-946 | 65862-0946-01 |
| 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 |
Other NDCs under ANDA 215936
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 Maleatedorzolamide hydrochloride and timolol maleate preservative free | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | Bryant Ranch Prepack | 72162-2387 |