Prescription drug · ANDA
Dorzolamide Hydrochloride and Timolol Maleate NDC 61314-030
Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL · Solution · Ophthalmic · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61314-030-01 | 6131400300161314003001 | 5 mL in 1 BOTTLE (61314-030-01)Marketed from Jan 2, 2010 | |
| 61314-030-02 | 6131400300261314003002 | 10 mL in 1 BOTTLE (61314-030-02)Marketed from Jan 2, 2010 |
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
- Route
- Ophthalmic
- Labeler
- Sandoz IncNDC labeler code 61314
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090604
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)Carbonic Anhydrase Inhibitors (Mechanism)
- Identifiers
- Product ID 61314-030_871f8fa0-dcd0-4f91-b76b-3403083d456dSPL ID 871f8fa0-dcd0-4f91-b76b-3403083d456d
- 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
N461314003001followed by a unit qualifier and the quantityPackage 61314-0030-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 61314-030
- What is NDC 61314-030?
- 61314-030 is the product NDC for Dorzolamide Hydrochloride and Timolol Maleate, Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL solution, listed with the FDA by Sandoz Inc. 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.
- What is the active ingredient?
- Dorzolamide hydrochloride, Timolol maleate.
- Who is the labeler?
- Sandoz Inc, NDC labeler code 61314. 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 | 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 | 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 090604
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 | Dorzolamide hydrochloride 20 mg/mL; Timolol maleate 5 mg/mL | SolutionOphthalmic | Bryant Ranch Prepack | 72162-2184 |