Prescription drug · ANDA
Timolol Maleate (Timolol maleate ophthalmic) NDC 42571-404
Timolol maleate 5 mg/mL · Solution/ drops · Ophthalmic · Micro Labs Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42571-404-21 | 4257104042142571040421 | 5 mL in 1 BOTTLE (42571-404-21)Marketed from Aug 1, 2023 | |
| 42571-404-88 | 4257104048842571040488 | 10 mL in 1 BOTTLE (42571-404-88)Marketed from Aug 1, 2023 |
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)
- Timolol Maleate
- Generic name (nonproprietary)
- timolol maleate ophthalmic
- Active ingredients
- Timolol 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 217343
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 42571-404_238fd036-1868-da83-e063-6394a90a0596SPL ID 238fd036-1868-da83-e063-6394a90a0596SPL set ID 6c9f3971-8c07-4d3a-915d-76438baa2a0bRxCUI 1923428, 1992303UNII P8Y54F701RUPC 0342571404215, 0342571403218
- Pharmacologic class
- 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
N442571040421followed by a unit qualifier and the quantityPackage 42571-0404-21. 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)
INDICATIONS AND USAGE Timolol maleate ophthalmic solution is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
Excerpt only. Read the full label for complete information.
About NDC 42571-404
- What is NDC 42571-404?
- 42571-404 is the product NDC for Timolol Maleate (timolol maleate ophthalmic), 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?
- Timolol Maleate (Timolol Maleate Ophthalmic).
- What is the active ingredient?
- 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 Timolol Maleate?
- 47 other product NDCs are listed under this name. See all 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 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) |
|---|---|---|---|---|---|
| Timolol Maleate | Timolol maleate 2.5 mg/mL | Solution, Gel forming / dropsOphthalmic | Sagent Pharmaceuticals | 25021-008 | 25021-0008-05 |
| Timolol Maleate | Timolol maleate 5 mg/mL | Solution, Gel forming / dropsOphthalmic | Sagent Pharmaceuticals | 25021-009 | 25021-0009-05 |
| Timolol Maleate | Timolol maleate 5 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-223 | 16571-0223-01 |
| Timolol Maleate | Timolol maleate 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-224 | 16571-0224-01 |
| Timolol Maleate | Timolol maleate 20 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-225 | 16571-0225-01 |
| timolol maleate | Timolol maleate 5 mg/mL | Solution/ dropsOphthalmic | NorthStar RxLLC | 72603-540 | 72603-0540-01 |
| Timolol Maleate | Timolol maleate 5 mg/mL | SolutionOphthalmic | Leading Pharma, LLC | 69315-325 | 69315-0325-0569315-0325-1069315-0325-15 |
| Timolol Maleate | Timolol maleate 2.5 mg/mL | Solution, Gel forming / dropsOphthalmic | Somerset Therapeutics, LLC | 70069-241 | 70069-0241-01 |
| Timolol Maleate | Timolol maleate 5 mg/mL | Solution, Gel forming / dropsOphthalmic | Somerset Therapeutics, LLC | 70069-251 | 70069-0251-01 |
| Timolol Maleate | Timolol maleate 5 mg/mL | SolutionOphthalmic | A-S Medication Solutions | 50090-7837 | 50090-7837-00 |
Other NDCs under ANDA 217343
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 |
|---|---|---|---|---|
| Timolol Maleatetimolol maleate ophthalmic | Timolol maleate 2.5 mg/mL | Solution/ dropsOphthalmic | Micro Labs Limited | 42571-403 |