Prescription drug · ANDA
Timolol Hemihydrate NDC 70069-698
Timolol anhydrous 5 mg/mL · Solution/ drops · Ophthalmic · Somerset Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70069-698-01 | 70069069801 | 1 BOTTLE in 1 CARTON (70069-698-01) / 15 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 Hemihydrate
- Generic name (nonproprietary)
- timolol hemihydrate
- Active ingredients
- Timolol anhydrous — 5 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Somerset Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216654
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 70069-698_c1213979-d6ff-44c2-ad97-1de99ddcf8d2SPL ID c1213979-d6ff-44c2-ad97-1de99ddcf8d2SPL set ID cebc9a5e-0bdb-4f23-9b2c-cde543b62fb6RxCUI 2702393UNII 5JKY92S7BRUPC 0370069697016, 0370069698013, 0370069696019
- 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
N470069069801followed by a unit qualifier and the quantityPackage 70069-0698-01. 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 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.
Other NDCs under ANDA 216654
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 Hemihydrate | Timolol anhydrous 5 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-697 |
| Timolol Hemihydrate | Timolol anhydrous 5 mg/mL | Solution/ dropsOphthalmic | Somerset Therapeutics, LLC | 70069-696 |