Prescription drug · ANDA
Timolol Maleate NDC 70069-241
Timolol maleate 2.5 mg/mL · Solution, Gel forming / drops · Ophthalmic · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-241-01 | 7006902410170069024101 | 1 BOTTLE in 1 CARTON (70069-241-01) / 5 mL in 1 BOTTLEMarketed from Oct 31, 2024 |
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
- Active ingredients
- Timolol maleate — 2.5 mg/mL
- Dosage form
- Solution, Gel forming / drops
- Route
- Ophthalmic
- Labeler
- Somerset Therapeutics, LLCNDC labeler code 70069
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210640
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 70069-241_a7b2ec00-1f4a-4058-a397-82d028d8476cSPL ID a7b2ec00-1f4a-4058-a397-82d028d8476cSPL set ID e797f7c7-0588-4627-b060-8df6bcfe3f7bRxCUI 313407, 313408UNII P8Y54F701RUPC 0370069251010, 0370069241011
- 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
N470069024101followed by a unit qualifier and the quantityPackage 70069-0241-01. 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)
INDICATIONS AND USAGE Timolol maleate ophthalmic gel forming 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 70069-241
- What is NDC 70069-241?
- 70069-241 is the product NDC for Timolol Maleate, Timolol maleate 2.5 mg/mL solution, gel forming / drops, listed with the FDA by Somerset Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Timolol Maleate.
- What is the active ingredient?
- Timolol maleate.
- Who is the labeler?
- Somerset Therapeutics, LLC, NDC labeler code 70069. 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 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 |
| Timolol Maleate | Timolol maleate 5 mg/mL | SolutionOphthalmic | Caplin Steriles Limited | 65145-152 | 65145-0152-01 |
Other NDCs under ANDA 210640
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 Maleate | Timolol maleate 5 mg/mL | Solution, Gel forming / dropsOphthalmic | Somerset Therapeutics, LLC | 70069-251 |